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

This study is currently recruiting participants.
Verified June 2012 by TEI Biosciences Inc.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT01228500
First received: October 25, 2010
Last updated: June 4, 2012
Last verified: June 2012
History of Changes

October 25, 2010
June 4, 2012
January 2008
January 2013   (final data collection date for primary outcome measure)
Time to healing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01228500 on ClinicalTrials.gov Archive Site
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The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Foot Ulcer, Diabetic
Device: PriMatrix
Dermal Repair Scaffold
Experimental: Experimental Arm (Internal Control)

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

Intervention: Device: PriMatrix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jeremy Cook, DPM 781-767-1923
United States
 
NCT01228500
TEI-001
Yes
Yiannis Monovoukas, TEI Biosciences Inc.
TEI Biosciences Inc.
Beth Israel Deaconess Medical Center
Principal Investigator: Jeremy Cook, DPM Beth Israel Deaconess Medical Center, Harvard Medical School
TEI Biosciences Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP