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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01228500
• Other study ID #: TEI-001
• Status: Withdrawn
• Phase: N/A
• First received: October 25, 2010
• Last updated: May 11, 2015
• Start date: January 2008

Study information

• Verified date: May 2015
• Source: TEI Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer, Diabetic

Intervention

Device:
• PriMatrix
Dermal Repair Scaffold

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
TEI Biosciences Inc.	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing		12 weeks	No