At a glance

ClinicalIndex Comparison Record

N/ACompleted· 39 enrolled

Drug / intervention

APM Graft (BIOTAPE XMTM) +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01353495

NCT01353495N/ACompleted

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

Stryker Trauma and Extremities·interventional·Posted May 13, 2011·Updated Jun 14, 2021

In Brief

A clinical study evaluating APM Graft (BIOTAPE XMTM) and Wound Debridement for Diabetic Foot Ulcers. Completed, enrolled 39 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetic Foot Ulcers

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartApr 2010

Primary CompletionOct 2010

Study CompletionApr 2011

First PostedMay 2011

TodayJul 2026

First PostedMay 13, 2011

Enrollment StartApr 1, 2010

Primary CompletionOct 1, 2010

Study CompletionApr 1, 2011

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 15.1 years ago

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.

Wound Debridementother

Wounds debrided in both arms of study