Clinical trial NCT02209051: Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
Official title: A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: Diabetic Foot Ulcers
AMNIOEXCEL
Wagner Grade 1 or 2 foot ulcers
Wound
Foot health
Ulcer
Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers

Detailed description: Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients will return two weeks later for assessment.

Upon return, per the original protocol, patient would have been randomized at \<20% closure; per Amendment 1, if the wound has closed \<30% in area during the 2 week Screening Period and all other eligibility criteria are met, the patient will be randomized (1:1) to receive either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.

All patients enrolled in this study will receive SOC. For the purposes of this study, Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will be applied after the wound has been debrided and hemostasis achieved. The wound will then be dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive dressing.

The patient will return once weekly for wound care, photographs and ulcer measurement. At each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon physician judgment. All patients complete their participation at Week 6.

This is an open label study and no attempt will be made to blind subjects or Investigators to randomization allocation.

Eligibility criteria: Inclusion Criteria:

1. an ambulatory person at least 18 years of age at the time of informed consent.
2. type 1 or type 2 diabetes mellitus.
3. glycosylated hemoglobin (HbA1c) of ≤12%
4. at least one wound that is/has:

   * Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
   * duration of at least 1 month,
   * no clinical signs of infection or osteomyelitis,
   * between 1cm2 and 25cm2 in area,
   * per original protocol, closed \<20% in area during the Screening Period; per Amendment #1, closed \<30% in area during Screening and
   * located on the foot, distal to malleoli.
5. adequate circulation to the affected extremity
6. serum creatinine of \<3.0mg/dl.

Exclusion Criteria:

1. participated in another clinical trial within 30 days prior to consent,
2. Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
3. receiving radiation or chemotherapy of any kind,
4. known or suspected malignancy of current ulcer,
5. pregnant or breast feeding,
6. an active malignant disease,
7. receiving hemo- or peritoneal dialysis,
8. sickle cell anemia or Raynaud's syndrome,
9. diagnosis of autoimmune connective tissue disease,
10. received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
11. exposed bone, tendon or joint capsule in the study ulcer,
12. currently receiving antibiotics (for any reason), or
13. taking medications considered to be immune system modulators.

Primary outcomes:
measure: Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to complete wound closure of the target ulcer
timeFrame: 8 weeks
measure: Rate of wound closure
timeFrame: 8 Weeks
measure: Incidence, severity and type of adverse events
timeFrame: 8 Weeks
measure: Changes in Quality of Life assessment
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot and Ankle Specialists, LLC
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Stockton
country: United States
facility: Pacific Wound Center
state: California
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: North Miami Beach
country: United States
facility: Barry University Clinical Research
state: Florida
city: Plymouth
country: United States
facility: Beth Israel Deaconess Hospital - Plymouth
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital
state: North Carolina
Study officials:
References:
citation: Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70-7.