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

Integra LifeSciences

Status: Withdrawn

Conditions: Foot Ulcer, Diabetic

Treatments: Device: PriMatrix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01228500

TEI-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 1 patient group

Experimental Arm (Internal Control)

Experimental group

Description:

One-half of ulcer receives negative pressure wound therapy One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy

Treatment:

Device: PriMatrix