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

Not Applicable

Withdrawn

• Conditions: Foot Ulcer, Diabetic
• Interventions: Device: PriMatrix

• Registration Number: NCT01228500
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2013-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-15
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm (Internal Control)	PriMatrix	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

Primary Outcome Measures

Name	Time	Method
Time to healing	12 weeks

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States