Clinical trial NCT03662997: Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Official title: A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wound
Venous Leg Ulcer
Diabetic Foot Ulcer
Keywords: Chronic wound
Venous Leg Ulcer
Diabetic Foot Ulcer
Wound dressing
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a prospective RCT using a crossover design to evaluate safety and efficacy. The study will be conducted in an outpatient setting of an academic clinical center. There will be two participant groups: those with VLU and those with DFU. Approximately 50% of the participants will be in the VLU group and 50% of the participants in the DFU group. Treatment sequence will be randomized so that a fair distribution is achieved. Each participant will receive a 2-week treatment with one of the three dressings followed by a 2-week treatment period with a second dressing (i.e. each participant will receive treatment with two different dressings, either the Bordered Five-Layer Foam Dressing and the Hydropolymer Foam Dressing, or the Bordered Five-Layer Foam Dressing and the Hydrocellular Multi-Layer Foam Dressing) using a cross-over (repeated measures) design, with a total of four study arms.
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.

Detailed description: The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).

The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus areas; efficacy and safety of the dressings, participant-centric outcomes and health economic evaluation.

Note: The terms used within the body of this report and results, in both the Primary and Secondary Outcomes, are defined as follows:

Period 1: Weeks 1 and 2 of study follow-up visits. Period 2: Weeks 3 and 4 of study follow-up visits. Week 1: Designates data captured only on visit days 7 and 21. Week 2: Designates data captured only on visit days 14 and 28. During Week 1: Designates data captured on visit days 3, 7, 17 and 21. During Week 2: Designates data captured on visit days 10, 14, 24 and 28. Day 3 of Week 1 from tables: inclusive of data captured on Visit Days 3 and 17. Day 3 of Week 2 from tables: inclusive of data captured on Visit Days 10 and 24.

Day 7 of Week 1 from tables: inclusive of data captured on Visit Days 7 and 21. Day 7 of Week 2 from tables: inclusive of data captured on Visit Days 14 and 28.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
2. Signed informed consent.
3. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
4. Study subject must be available and able to visit the clinic weekly for the full 4-week period.

Exclusion Criteria:

1. Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
2. Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
3. Subject has any evidence of peripheral arterial disease (PAD).
4. Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
5. Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
6. Pregnancy or lactation at time of study participation.
7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
8. Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
9. Present history of alcohol or drug abuse.
10. Known allergy/hypersensitivity to any of the components of the dressing.
11. Subject not suitable for the investigation according to the investigator's judgment.

Primary outcomes:
measure: % of Participants With Equal or Better Rate of Dressing Durability
timeFrame: 4 weeks
measure: % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
timeFrame: Weeks 1 and 3
Secondary outcomes:
measure: % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer
timeFrame: 4 weeks
measure: % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer
timeFrame: 4 weeks
measure: % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer
timeFrame: 4 weeks
measure: % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings
timeFrame: 4 weeks
measure: % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation
timeFrame: 4 weeks
measure: % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both)
timeFrame: 4 weeks
measure: Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: San Francisco
country: United States
facility: Center for Clinical Trials, Inc.
state: California
city: Newark
country: United States
facility: Vascular and Wound Care Center
state: New Jersey
city: Pittsburgh
country: United States
facility: SerenaGroup Research Foundation
state: Pennsylvania
city: Pittsburgh
country: United States
facility: SerenaGroup
state: Pennsylvania
Study officials:
affiliation: Vascular and Wound Care Center, University Hospital, Newark, NJ, USA
name: Oscar Alvarez
role: PRINCIPAL_INVESTIGATOR
References: