Abstract
Diabetic foot ulcers often pose a difficult treatment problem. Repeated applications of cell-based products have been reported to result in acceleration of diabetic wound healing. The purpose of this clinical trial study was to report preliminary findings of the efficacy and safety of the cultured allogeneic keratinocyte sheets in the treatment of diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the keratinocyte treatment group (n = 27) or the control group treated with vaseline gauze (n = 32). Except for the application of keratinocytes, treatment of study ulcers was identical for patients in both groups. Either keratinocyte sheet or vaseline gauze was applied at the beginning of the study and weekly thereafter for a maximum of 11 weeks. The maximum follow-up period for each patient was 12 weeks. Complete ulcer healing was achieved in 100% of the treatment group and 69% of the control group (p < 0.05). The Kaplan-Meier median times to complete closure were 35 and 57 days for the keratinocyte and control groups, respectively. No adverse events related to the treatment occurred. These results indicate that cultured allogeneic keratinocytes may offer a safe and effective treatment for diabetic foot ulcers.
| Original language | English |
|---|---|
| Pages (from-to) | 491-499 |
| Number of pages | 9 |
| Journal | Wound Repair and Regeneration |
| Volume | 20 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 2012 Jul 1 |
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ASJC Scopus subject areas
- Dermatology
- Surgery
Cite this
Treatment of diabetic foot ulcers using cultured allogeneic keratinocytes - A pilot study. / You, Hijin; Han, Seung-Kyu; Lee, Jin Woo; Chang, Hak.
In: Wound Repair and Regeneration, Vol. 20, No. 4, 01.07.2012, p. 491-499.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Treatment of diabetic foot ulcers using cultured allogeneic keratinocytes - A pilot study
AU - You, Hijin
AU - Han, Seung-Kyu
AU - Lee, Jin Woo
AU - Chang, Hak
PY - 2012/7/1
Y1 - 2012/7/1
N2 - Diabetic foot ulcers often pose a difficult treatment problem. Repeated applications of cell-based products have been reported to result in acceleration of diabetic wound healing. The purpose of this clinical trial study was to report preliminary findings of the efficacy and safety of the cultured allogeneic keratinocyte sheets in the treatment of diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the keratinocyte treatment group (n = 27) or the control group treated with vaseline gauze (n = 32). Except for the application of keratinocytes, treatment of study ulcers was identical for patients in both groups. Either keratinocyte sheet or vaseline gauze was applied at the beginning of the study and weekly thereafter for a maximum of 11 weeks. The maximum follow-up period for each patient was 12 weeks. Complete ulcer healing was achieved in 100% of the treatment group and 69% of the control group (p < 0.05). The Kaplan-Meier median times to complete closure were 35 and 57 days for the keratinocyte and control groups, respectively. No adverse events related to the treatment occurred. These results indicate that cultured allogeneic keratinocytes may offer a safe and effective treatment for diabetic foot ulcers.
AB - Diabetic foot ulcers often pose a difficult treatment problem. Repeated applications of cell-based products have been reported to result in acceleration of diabetic wound healing. The purpose of this clinical trial study was to report preliminary findings of the efficacy and safety of the cultured allogeneic keratinocyte sheets in the treatment of diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the keratinocyte treatment group (n = 27) or the control group treated with vaseline gauze (n = 32). Except for the application of keratinocytes, treatment of study ulcers was identical for patients in both groups. Either keratinocyte sheet or vaseline gauze was applied at the beginning of the study and weekly thereafter for a maximum of 11 weeks. The maximum follow-up period for each patient was 12 weeks. Complete ulcer healing was achieved in 100% of the treatment group and 69% of the control group (p < 0.05). The Kaplan-Meier median times to complete closure were 35 and 57 days for the keratinocyte and control groups, respectively. No adverse events related to the treatment occurred. These results indicate that cultured allogeneic keratinocytes may offer a safe and effective treatment for diabetic foot ulcers.
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U2 - 10.1111/j.1524-475X.2012.00809.x
DO - 10.1111/j.1524-475X.2012.00809.x
M3 - Article
C2 - 22672334
AN - SCOPUS:84863498506
VL - 20
SP - 491
EP - 499
JO - Wound Repair and Regeneration
JF - Wound Repair and Regeneration
SN - 1067-1927
IS - 4
ER -