Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT01353495
Recruitment Status :
First Posted : May 13, 2011
Last Update Posted : June 7, 2011
Wright Medical Technology
Advanced Foot Care and Clinical Research Center
Providence Health Partners Center for Clinical Research
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.
We will evaluate the influence of continuous variables' effect on healing in general using a Mann Whitney U test. Dichotomous variables will be evaluated with a chi-squared test with odds ratio and 95% confidence interval (CI). To evaluate the healing characteristics of each modality as a function of weeks of therapy and mean number of days to closure amongst patients healing within the 12-week study period, we will use a Kaplan-Meier life table analysis (log-rank test).
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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