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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228500
First Posted: October 26, 2010
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Integra LifeSciences Corporation
October 25, 2010
October 26, 2010
May 17, 2016
January 2008
January 2013   (Final data collection date for primary outcome measure)
Time to healing [ Time Frame: 12 weeks ]
Not Provided
Complete list of historical versions of study NCT01228500 on ClinicalTrials.gov Archive Site
Not Provided
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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 (Participant, 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.
 
Withdrawn
0
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01228500
TEI-001
Yes
Not Provided
Not Provided
Integra LifeSciences Corporation
Integra LifeSciences Corporation
Beth Israel Deaconess Medical Center
Principal Investigator: Jeremy Cook, DPM Beth Israel Deaconess Medical Center, Harvard Medical School
Integra LifeSciences Corporation
May 2016

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