Abstract | OBJECTIVE: METHODS: Forty-six subjects were randomized (double-blind) 1:1 to the test or control group and treated for up to 4 months. Subjects had Wagner grade I ulcers with wound area of 1 cm2 to 16 cm2 without severe peripheral arterial disease, osteomyelitis, or any infection requiring antibiotics. Study medication was applied daily and casts changed approximately every 14 days. RESULTS: Of the 46 subjects randomized, 38 either healed or completed 16 weeks of therapy without healing. Eight subjects dropped out prior to 16 weeks. Based on intention-to-treat, 12 of 23 (52%) test group subjects healed before 16 weeks compared to 13 of 23 (57%) control group subjects (not significant). Regression analysis demonstrated that slower healing was associated with larger initial wound size (hazard radio [HR] = 0.997, 95% confidence interval [CI]: 0.995-1.00, P = 0.028) and excessive wound drainage (HR = 0.346, 95% CI: 0.126-0.948, P = 0.039). Excluding the patients who dropped out, 25 of 38 (66%) subjects healed by 4 months. Three additional subjects healed with casts that were worn longer than 4 months, for an overall rate of 74% at 9 months. Five subjects developed cast burns, and 3 patients required amputation. CONCLUSION: Topical platelet derived growth factor does not appear to significantly improve healing of Wagner grade I diabetic foot ulcers that are treated by offloading with a short leg walking cast. Excellent healing rates may be achieved with casting alone.
|
Authors | Christine Ma, Michael A Hernandez, Vincent E Kirkpatrick, Li-Jung Liang, Aksone L Nouvong, Ian I Gordon |
Journal | Wounds : a compendium of clinical research and practice
(Wounds)
Vol. 27
Issue 4
Pg. 83-91
(Apr 2015)
ISSN: 1943-2704 [Electronic] United States |
PMID | 25855851
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Platelet-Derived Growth Factor
- Recombinant Proteins
|
Topics |
- Administration, Cutaneous
- Casts, Surgical
- Chronic Disease
- Diabetic Foot
(drug therapy, pathology)
- Double-Blind Method
- Drainage
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Platelet-Derived Growth Factor
(therapeutic use)
- Recombinant Proteins
(therapeutic use)
- Treatment Outcome
- Wound Healing
(drug effects)
|