Topical Platelet Derived Growth Factor (PDGF) Versus Placebo Therapy of Diabetic Foot Ulcers Off-Loaded with Windowed Casts
Not Applicable
Completed
- Conditions
- Diabetic Foot UlcerSurgery - Other surgeryMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12612001124820
- Lead Sponsor
- Heritage Provider Network, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 46
Inclusion Criteria
Wagner Grade 1 Diabetic Foot Ulcer, ulcer area between 1-16 square centimerters
Exclusion Criteria
Wagner Grade 2 ulcer or above, osteomyelitis or infection requiring antibiotics, ulcer area outside of range 1-16 square centimeters, more then two full thickness wounds on the involved extremity, moderate to severe peripheral arterial disease (ABI < 0.7), concomitant use of Pletal (cilostazol), inability to tolerate casting or unsteady gait, active neoplasia, concomitant steroid use, chronic alcohol or drug abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is ulcer healing rate at four months. Clinical assessments were scheduled every two weeks from randomization until 4 months of treatment were complete. The assessments consisted of removal of the cast window for wound inspection. Healing was defined as complete epithelialization of the wound.[Every two weeks from randomization until four months of treatment were complete.]
- Secondary Outcome Measures
Name Time Method The patients with unhealed ulcers at 4 months were followed until wound healing or amputation. These final results for ulcer healing are included in the data and thus can be considered a secondary outcome. At nine months after randomization all patients had either healed, dropped out of the study or had an amputation of the affected limb.[nine months]