BACKGROUND: A number of different treatment approaches have been recommended for the treatment of venous ulceration, including local ulcer treatment, compression and drug therapy. Recent advances in tissue engineering have resulted in living tissues being developed for cutaneous wound repair and skin replacement. The aim of this pilot study was to compare the rate of healing of venous ulcers in patients treated with Dermagraft (a human fibroblast-derived dermal replacement) andcompression therapy or compression therapy alone. METHODS: A total of 18 patients with venous ulceration of the leg were recruited into the pilot study. Ten patients were treated with Dermagraft and compression therapy, and eight patients were treated with compression therapy alone. Healing was assessed by ulcer tracing and computerised planimetry. Skin perfusion was measured by laser Doppler. RESULTS: Five (50%) of the patients treated with Dermagraft and one (12.5%) control patient had healed by the end of the 12-week study period (NS). The total ulcer area rate of healing and linear rate of healing was significantly improved in patients treated with Dermagraft (P=0.001 and P=0.006, respectively, Mann-Whitney U-test). The number of capillaries increased in both the treatment and control group. Peri-ulcer skin perfusion increased by 20% in patients treated with Dermagraft, compared with 4.9% in the control group. CONCLUSION: The data from this small pilot study suggests that Dermagraft is associated with improved healing of venous ulceration. Following this pilot study, further clinical studies are needed to confirm the validity of these results in 'hard to heal' venous leg ulcers.
RCT Entities:
BACKGROUND: A number of different treatment approaches have been recommended for the treatment of venous ulceration, including local ulcer treatment, compression and drug therapy. Recent advances in tissue engineering have resulted in living tissues being developed for cutaneous wound repair and skin replacement. The aim of this pilot study was to compare the rate of healing of venous ulcers in patients treated with Dermagraft (a human fibroblast-derived dermal replacement) and compression therapy or compression therapy alone. METHODS: A total of 18 patients with venous ulceration of the leg were recruited into the pilot study. Ten patients were treated with Dermagraft and compression therapy, and eight patients were treated with compression therapy alone. Healing was assessed by ulcer tracing and computerised planimetry. Skin perfusion was measured by laser Doppler. RESULTS: Five (50%) of the patients treated with Dermagraft and one (12.5%) control patient had healed by the end of the 12-week study period (NS). The total ulcer area rate of healing and linear rate of healing was significantly improved in patients treated with Dermagraft (P=0.001 and P=0.006, respectively, Mann-Whitney U-test). The number of capillaries increased in both the treatment and control group. Peri-ulcer skin perfusion increased by 20% in patients treated with Dermagraft, compared with 4.9% in the control group. CONCLUSION: The data from this small pilot study suggests that Dermagraft is associated with improved healing of venous ulceration. Following this pilot study, further clinical studies are needed to confirm the validity of these results in 'hard to heal' venous leg ulcers.
Authors: Eliot Mostow; Jon D Montemayor; Sean Pittinger; Stephannie Miller; Kimberly N Blasiole; Judith Fulton Journal: Adv Wound Care (New Rochelle) Date: 2014-08-01 Impact factor: 4.730
Authors: Whitney L Stoppel; Chiara E Ghezzi; Stephanie L McNamara; Lauren D Black; David L Kaplan Journal: Ann Biomed Eng Date: 2014-12-24 Impact factor: 3.934