Foot Ulcer, Diabetic
Conditions
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.
Interventions
DEVICEPriMatrix
Dermal Repair Scaffold
Sponsors
Beth Israel Deaconess Medical Center
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to healing | 12 weeks |
Countries
United States
Outcome results
None listed