None listed
Conditions
Brief summary
The was a multi-centered, randomized, controlled study to evaluate the efficacy of topical platelet derived growth factor (PDGF) in the treatment of diabetic foot ulcers. Forty six male patients with Wagner Grade 1 diabetic foot ulcers were randomized to treatment with PDGF hydrogel (tradename Regranex) versus placebo hydrogel, and all patients received treatment with a windowed cast for ulcer off-loading. Patients with abscess, osteomyelitis or infection requiring antibiotics were excluded. The patients were evaluated at four months after randomization for wound healing. Fifty two percent of the patients treated with PDGF plus windowed casts healed at four months compared to 57% of the placebo patients, yielding a non-significant p-value 0.79. Regranex gel does not appear to improve ulcer healing when combined with effective off-loading. Windowed casting is a safe and effective means of treating diabetic foot ulcers.
Interventions
All patients had the affected leg treated with a short leg walking cast windowed over the ulcer. The cast consists of five layers: a thick hydrocolloid protective layer applied directly to the skin around the wound; then a layer of cotton gauze; then water resistant foam padding; then cotton padding; then fiberglass. A window is then cut with a cast saw over a pre-marked area of the cast that is over the ulcer. The cast application process takes approximately one hour. This was continued for 4 m
All patients had the affected leg treated with a short leg walking cast windowed over the ulcer. The cast consists of five layers: a thick hydrocolloid protective layer applied directly to the skin around the wound; then a layer of cotton gauze; then water resistant foam padding; then cotton padding; then fiberglass. A window is then cut with a cast saw over a pre-marked area of the cast that is over the ulcer. The cast application process takes approximately one hour. This was continued for 4 months with evaluation every two weeks. The PDGF gel was applied daily to the ulcer approximately 2 mm thick after cleaning the ulcer with saline. A bandage was applied over the gel and the window in the cast was then replaced and taped in place.
Sponsors
Heritage Provider Network, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No
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
Outcome results
None listed