A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers.
OBJECTIVE
Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers.


METHODS
Randomized, prospective, controlled multicenter trial.


METHODS
University teaching hospitals and primary care centers.


METHODS
A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer.


METHODS
Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks.


METHODS
Complete healing of the study ulcer (wound).


RESULTS
After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze.


CONCLUSIONS
Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.
Veves
Aristidis
A
Joslin Beth Israel Deaconess Foot Center, One Deaconess Rd, Boston, MA 02215, USA. aveves@caregroup.harvard.edu
Sheehan
Peter
P
Pham
Hau T
HT
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001458:Bandages; D002483:Cellulose, Oxidized / Q000627:therapeutic use*; D003094:Collagen / Q000627:therapeutic use*; D017719:Diabetic Foot / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D002483:Cellulose, Oxidized; D006490:Hemostatics; D003094:Collagen