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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2016
• Main ID: NCT01228500
• Date of registration: 25/10/2010
• Prospective Registration: No
• Primary sponsor: Integra LifeSciences Corporation
• Public title: The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
• Scientific title: The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
• Date of first enrolment: January 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01228500
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Jeremy Cook, DPM
• Affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Foot Ulcer, Diabetic

Intervention(s)

Device: PriMatrix

Primary Outcome(s)

Time to healing [Time Frame: 12 weeks]

Secondary ID(s)

TEI-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beth Israel Deaconess Medical Center