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

NCT ID: NCT01353495

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-04-30

Brief Summary

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

Detailed Description

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

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APM Graft (BIOTAPE XMTM

graft applied to wound q 3 weeks for 12 weeks

Group Type: EXPERIMENTAL

APM Graft (BIOTAPE XMTM)

Intervention Type: DEVICE

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.

Wound Debridement

Intervention Type: OTHER

Wounds debrided in both arms of study

standard wound care

Wound debridement and gels and foams applied to wound weekly for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Wound Debridement

Intervention Type: OTHER

Wounds debrided in both arms of study

Interventions

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.

Intervention Type: DEVICE

Wound Debridement

Wounds debrided in both arms of study

Intervention Type: OTHER

Other Intervention Names

BIOTAPE XMTM

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jagpreet Mukker, DPM

Role: PRINCIPAL_INVESTIGATOR

Advanced Foot Care and Clinincal Research Center

Locations

Advanced Foot Care and Clinincal Research Center

Fresno, California, United States

Professional Education & Research Institute

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

009-BIO-001

Identifier Type: -

Identifier Source: org_study_id