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

NCT01353495 | Completed Results

• 1 other identifier: 009-BIO-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Diabetic Foot Ulcers

Keywords

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

APM Graft (BIOTAPE XMTM

EXPERIMENTAL

graft applied to wound q 3 weeks for 12 weeks

Device: APM Graft (BIOTAPE XMTM); Other: Wound Debridement

standard wound care

ACTIVE COMPARATOR

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

Other: Wound Debridement

Interventions

APM Graft (BIOTAPE XMTM) 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.

Also known as: BIOTAPE XMTM

APM Graft (BIOTAPE XMTM

Wound Debridement OTHER

Wounds debrided in both arms of study

APM Graft (BIOTAPE XMTM; standard wound care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (2)

Advanced Foot Care and Clinincal Research Center

Fresno, California, 93722, United States

Location

Professional Education & Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Jonette Hodge, MSN, RN, CCRP, Director, Medical Affairs
• Organization: Wright Medical Technology, Inc.

jonette.hodge@wmt.com

8002387188

Study Officials

• Jagpreet Mukker, DPM

  Advanced Foot Care and Clinincal Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 13, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)