The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

Withdrawn before enrolling · Not applicable

Conditions studied: Foot Ulcer, Diabetic

In brief

The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.

Key facts

Study ID: NCT01228500
Run by: Integra LifeSciences Corporation
People needed: 0
Starts: 2008-01-01
Last updated by the study team: 2016-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult Type 1 or 2 diabetic patients that present with foot ulcers.
Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
All ulcer durations will be eligible
Patients currently receiving NPWT for a diabetic foot ulcer
Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.

You may not qualify if…

Active foot infections
Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
Patients who are pregnant
Allergies to any material contained within the NPWT or bioscaffold
Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines

Where it is running

Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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