Study: NCT02470806

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Fluid collection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Thigh
Frequency: 1 affected / 80 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Psychiatric evaluation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Target ulcer increase in size > 75% from Baseline
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Excessive maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Deep venous thrombosis right lower leg
Serious: no
Organ System: Vascular disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Target venous leg ulcer maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Subject could not tolerated NPWT, it was uncomfortable for the subject
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Target ulcer infection
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered moderate.
Frequency: 2 affected / 80 at risk

Adverse event: Cellulitis to left 3rd interspace
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Right ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Right thigh fluid collection with right groin incision site related drainage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Venous stasis ulcer pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Vascular disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Left ankle swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Left sole wound infection
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Allergic contact dermatitis of skin surrounding right foot ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Stasis dermatitis, xerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Peri-wound maceration on left foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Peri-wound maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 6 affected / 80 at risk

Adverse event: Blistered skin right lower extremity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Probable osteomyelitis right foot at target ulcer
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Redness, swelling, and discomfort right leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Worsening of coronary artery disease
Serious: no
Organ System: Cardiac disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Femur fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Skin tear adjacent to target ulcer on left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Three skin tears 2 cm away from target wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Non-target wound on right lateral ankle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 2 affected / 80 at risk

Adverse event: Two skin tears away from target wound (anterior)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Two skin tears posterior to left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Multple skin tears from target wound anterior left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Non-target wound on left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Small irritations around where dressing puts pressure on left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Wet gangrene 4th digit left foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Large amount of drainage from target ulcer, left leg calf
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Suspected non-target ulcer infection
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Osteomyelitis of ankle/foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered moderate.
Frequency: 2 affected / 80 at risk

Adverse event: Bilateral lower extremity edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 2 affected / 80 at risk

Adverse event: Dyspnea on exertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Acute urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Complication of Foley catheter
Serious: no
Organ System: Renal and urinary disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Acute abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Edema, unspecified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Intermittent burning/stabbing pain x1 week
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Left side of nose epidermal inclusion cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Left lower abdomen epidermal cyst inflamed
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Left lower leg swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Prolonged pain at target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: The AE was considered mild.
Frequency: 3 affected / 80 at risk

Adverse event: Bone exposure at target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Wound undermining < 2 cm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 3 affected / 80 at risk

Adverse event: Bulla right foot lateral side
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Progressive disease - wound size met the definition of progressive disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Burning pain in foot of target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Contact dermatitis on left foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Acute on chronic congestive heart failure
Serious: no
Organ System: Cardiac disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Left ankle and lower leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Body rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Additional ulcer left ankle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Right mid thigh lacerations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Increased maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Fracture of vertebral disk
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 80 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Redness, skin breakdown to target limb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 80 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 84 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Acute-on-chronic
Frequency: 2 affected / 84 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ulcer increased in size
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Target ulcer increase in size > 75% from Baseline
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 84 at risk

Adverse event: Excessive maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Excessive intermittent maceration right plantar forefoot target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Intermittent events caused intermittent stoppages in therapy. The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Right lateral midfoot blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Increased peri-wound maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Peri-ulcer tissue very macerated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Left foot target ulcer cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Target ulcer infection
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered moderate.
Frequency: 3 affected / 84 at risk

Adverse event: Subjective complaint of ulcer pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Abrasion at 10 o'clock from left distal dorsal TMA
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Cellulitis of left plantar medial midfoot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Allergic contact dermatitis of the right leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Stasis dermatitis, xerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Stasis dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Erythema intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Peri-wound margin increase in maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Wound increased in size
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Regression in wound - size of wound increased by more than 75% from last visit
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Peri-wound maceration on right foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Wound macerated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Pressure-related pain from negative pressure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Peri-wound maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 6 affected / 84 at risk

Adverse event: Pruritus RLE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Excoriations, maceration peri-wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Macerated skin left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Progressive disease - worsening of target ulcer causing subject to be discontinued from study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Infected pimple on face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: DFU (target ulcer) progressive disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Target wound pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: New non-target ulcer near target ulcer on right shin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: New non-target ulcer near target ulcer 0.5 cm in size
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Target wound pain decreased
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Debridement pain on target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 84 at risk

Adverse event: Right upper quadrant/back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Non-target ulcer on lateral side of left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Multiple skin tears around target ulcer site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Water blister on medial side of left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 4 affected / 84 at risk

Adverse event: Left medial ankle venous leg ulcer bacterial colonization of wound bed
Serious: no
Organ System: Infections and infestations
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Peri-wound skin irritated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Right target ulcer larger
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Venous ulcer right leg malleolus increase in wound size
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Cellulitis of right foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Peri-wound inflammation target leg left VLU
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Foot blistering on dorsal and medial surface
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Formed a blister on anterior shin from tNPWT bridge
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Venous leg ulcer on left lateral leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Ulcer on dorsal portion of right foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Worsening of left ankle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal pain, epigastric
Serious: no
Organ System: Gastrointestinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Episode of recurrent major depressive disorder
Serious: no
Organ System: Psychiatric disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Suspected cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Target ulcer pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Scrotal oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Contact dermatitis on left foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk

Adverse event: Reopening of ulcers on target limb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Worsening of recurring non-target ulcers on target limb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered moderate.
Frequency: 1 affected / 84 at risk

Adverse event: Worsening of target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 84 at risk

Adverse event: Swelling of the right foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE was considered mild.
Frequency: 1 affected / 84 at risk