Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.

Detailed Description
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The primary objective of this study is time -to - healing with wound size determination at 12 weeks.

Official Title
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A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: APM Graft (BIOTAPE XMTM)
* Other: Wound Debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria and Population: Male or female age 18 or older Informed consent must be obtained Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement. Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA). Patient's ulcer must exhibit no clinical signs of infection. Patient is of legal consenting age. Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days: Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR ABIs with results of ≥0.7 and ≤1.2, OR Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg Exclusion Criteria: Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe. Patients whose index diabetic foot ulcers are greater than 25cm2. Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days, Patients whose serum creatinine levels are 3.0mg/dl or greater. Patients with a known history of poor compliance with medical treatments. Patients who have been previously randomized into this study, or are presently participating in another clinical trial Patients who are currently receiving radiation therapy or chemotherapy. Patients with known or suspected local skin malignancy to the index diabetic ulcer. Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center. Patients diagnosed with autoimmune connective tissues diseases. Nonrevascularable surgical sites Active infection at site Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin Any pathology that would limit the blood supply and compromise healing; Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days

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: APM Graft (BIOTAPE XMTM<br>graft applied to wound q 3 weeks for 12 weeks | Device: APM Graft (BIOTAPE XMTM)<br>* Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.<br>* Other names: BIOTAPE XMTM;Other: Wound Debridement<br>* Wounds debrided in both arms of study<br>|
| Active Comparator: standard wound care<br>Wound debridement and gels and foams applied to wound weekly for 12 weeks. | Other: Wound Debridement<br>* Wounds debrided in both arms of study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth | Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcers