A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.

Official Title
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A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers

Conditions
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Neuropathic Diabetic Ulcer - Foot

Intervention / Treatment
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* Device: Integra® Dermal Regeneration Template
* Other: Conventional Wound Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type I or Type II diabetes mellitus Glycosylated hemoglobin, HbA1c, ≤ 12% Negative serum pregnancy test at screening for female participants of child-bearing potential Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes At least one DFU that met the following criteria: Ulcer was diagnosed as a full-thickness neuropathic DFU that was located distal to the malleolus (excluding ulcers between the toes but including those of the heel), Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement), Area greater than or equal to 1 square centimeter and less than or equal to 12 square centimeters (post debridement at the time of randomization), Wagner grade 1 or 2, Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts, Duration of the study ulcer was at least 30 days at the time of the screening visit Adequate vascular perfusion of the affected limb Exclusion Criteria: Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb History of hypersensitivity to bovine collagen and/or chondroitin. Pregnancy Previous treatment under this clinical protocol Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit. Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing Any unstable condition or circumstance that could interfere with treatment regimen compliance Excessive lymphedema that could interfere with wound healing Unstable Charcot foot or Charcot with boney prominence Ulcers secondary to a disease other than diabetes Osteomyelitis with necrotic soft bone Chopart amputation History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of randomization or scheduled to receive such treatment during the study Non-study ulcer requiring treatment that could not be treated during the study with moist wound therapy History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process Employees or relatives of any member of the investigational site or sponsor Size of the study ulcer following debridement decreased by more than 30% during the run in period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermal Replacement Device<br>Device: INTEGRA® Dermal Regeneration Template | Device: Integra® Dermal Regeneration Template<br>* Application of Integra® Dermal Regeneration Template in diabetic foot ulcer<br>|
| Active Comparator: Moist Wound Therapy<br>0.9% Saline gel | Other: Conventional Wound Therapy<br>* Conventional Wound Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Complete Wound Closure | 100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Complete Wound Closure | Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase. | 16 weeks | 
| Time to Complete Wound Closure | Measures the time to complete wound closure as assessed by the Investigator. | 16 weeks | 
| Time to Complete Wound Closure | Time to complete wound closure, as assessed by computerized planimetry. | 16 weeks | 
| Rate of Wound Closure | Rate of wound closure as assessed by computerized planimetry | 16 weeks | 
| Incidence of Ulcer Recurrence | Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase. | 12 weeks | 
| Change in Short Form Health Survey (SF-36) Quality of Life Metrics | Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status. | Baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Healing, Integra Dermal Regeneration Template, Full Thickness, Foot Ulcer, Diabetic, Neuropathic, Omnigraft