Foot Ulcers, Diabetic Clinical Trial
| Verified date | August 2016 |
| Source | Integra LifeSciences Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type I or Type II diabetes with investigator-confirmed reasonable metabolic control - Peripheral neuropathy - A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area - An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening Exclusion Criteria: - Suspected or confirmed signs/symptoms of wound infection - Wounds with exposed bone or tendon - Hypersensitivity to bovine collagen |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Circleville Foot & Ankle | Circleville | Ohio |
| United States | New York College of Podiatric Medicine | New York | New York |
| United States | California School of Podiatric Medicine at Samuel Merritt University | Oakland | California |
| United States | Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Integra LifeSciences Corporation | Circleville Foot & Ankle LLC, Mayo Clinic, New York College of Podiatric Medicine, Samuel Merritt University, Temple University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent of study ulcers healed | Week 12 | No |