The healing properties of Promogran in venous leg ulcers.
OBJECTIVE
To evaluate the healing rate of venous leg ulcers treated with Promogran.


METHODS
Patients with stagnating venous leg ulcers were recruited. Target wounds were > or = 2 cm but < or = 10 cm in any one dimension. Subjects were randomly allocated to receive either Promogran or a non-adherent dressing (Adaptic) with a secondary dressing of gauze followed by short-stress compression (Biflex). Weekly wound assessments occurred over 12 weeks and dressings were changed twice weekly by the investigator and/or nurse team. Planimetry tracings and photographs were blindly reviewed and assessed by two independent investigators. An intent-to-treat analysis was performed.


RESULTS
Seventy-three patients were included. Thirty-seven were randomly allocated Promogran and 36 Adaptic. Twenty-nine patients completed the 12-week follow-up visit, 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing. Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing (22.2% versus 5.4%; p = 0.035). Eleven venous leg ulcers healed in the control group (31%) and 15 in the Promogran group (41%) (p = 0.373). Overall, 15 venous leg ulcers healed or improved in the control group (42%) and 23 in the Promogran group (62%) (p = 0.079). Surface area decreased, on average, by 36.5 +/- 11.4% (median decrease: 44.6%) in the Adaptic group and by 54.4 +/- 10.9% (median decrease: 82.4%) in the Promogran group (p < 0.001). A < or = 20% surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group (42% versus 19%; p = 0.034). No severe local adverse events were noted in either group, although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group. Dressing acceptability was good or excellent in more than 60% of subjects in both groups.


CONCLUSIONS
The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current standard of care.
Vin
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Hôpital Américain, Neuilly, France. FVin@aol.com
Teot
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Meaume
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017438:Bisphenol A-Glycidyl Methacrylate / Q000627:therapeutic use; D002483:Cellulose, Oxidized / Q000627:therapeutic use*; D003094:Collagen / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014945:Wound Healing
D002483:Cellulose, Oxidized; D004338:Drug Combinations; D017438:Bisphenol A-Glycidyl Methacrylate; D003094:Collagen