Veves A, Sheehan P, Pham HT, et al.
Archives of surgery (Chicago, Ill. : 1960). Date of publication 2002 Jul 1;volume 137(7):822-7.
1. Arch Surg. 2002 Jul;137(7):822-7.
A randomized, controlled trial of Promogran (a collagen/oxidized regenerated
cellulose dressing) vs standard treatment in the management of diabetic foot
ulcers.
Veves A(1), Sheehan P, Pham HT.
Author information:
(1)Joslin Beth Israel Deaconess Foot Center, One Deaconess Rd, Boston, MA 02215,
USA. aveves@caregroup.harvard.edu
HYPOTHESIS: Promogran, a wound dressing consisting of collagen and oxidized
regenerated cellulose, is more effective that standard care in treating chronic
diabetic plantar ulcers.
DESIGN: Randomized, prospective, controlled multicenter trial.
SETTING: University teaching hospitals and primary care centers.
PATIENTS: 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.
INTERVENTIONS: 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.
MAIN OUTCOME MEASURE: 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.
PMID: 12093340 [Indexed for MEDLINE]
