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

This study has been completed.
Sponsor:
Collaborators:
Advanced Foot Care and Clinical Research Center
Providence Health Partners Center for Clinical Research
Information provided by:
Wright Medical Technology
ClinicalTrials.gov Identifier:
NCT01353495
First received: May 11, 2011
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Diabetic Foot Ulcers
Device: APM Graft (BIOTAPE XMTM)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Wright Medical Technology:

Primary Outcome Measures:
  • Mann Whitney U Test [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: APM Graft (BIOTAPE XMTM)
    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.
    Other Name: BIOTAPE XMTM
Detailed Description:

The primary objective of this study is to have ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) protocol in the management of indolent diabetic ulcers at 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353495

Locations
United States, California
Advanced Foot Care and Clinincal Research Center
Fresno, California, United States, 93722
United States, Virginia
Professional Education & Research Institute
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Wright Medical Technology
Advanced Foot Care and Clinical Research Center
Providence Health Partners Center for Clinical Research
Investigators
Principal Investigator: Jagpreet Mukker, DPM Advanced Foot Care and Clinincal Research Center
  More Information

No publications provided

Responsible Party: Wright Medical Technology, Inc, Wright Medical Technology, Inc.
ClinicalTrials.gov Identifier: NCT01353495     History of Changes
Other Study ID Numbers: 009-BIO-001
Study First Received: May 11, 2011
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wright Medical Technology:
Diabetic Foot Ulcers

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 22, 2014