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

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ClinicalTrials.gov Identifier: NCT01228500
Recruitment Status : Withdrawn
First Posted : October 26, 2010
Last Update Posted : May 17, 2016
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Foot Ulcer, Diabetic Device: PriMatrix

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
Study Start Date : January 2008
Primary Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arm Intervention/treatment
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

Device: PriMatrix
Dermal Repair Scaffold

Primary Outcome Measures :
  1. Time to healing [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228500

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Sponsors and Collaborators
Integra LifeSciences Corporation
Beth Israel Deaconess Medical Center
Principal Investigator: Jeremy Cook, DPM Beth Israel Deaconess Medical Center, Harvard Medical School

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01228500     History of Changes
Other Study ID Numbers: TEI-001
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Diabetic Angiopathies
Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies