Tags

Type your tag names separated by a space and hit enter

Apligraf in the treatment of neuropathic diabetic foot ulcers.
Int J Low Extrem Wounds 2009; 8(1):11-8IJ

Abstract

This study compared the efficacy and safety of Apligraf (Organogenesis, Inc., Canton, MA) in combination with standard therapy versus standard therapy alone in the treatment of neuropathic diabetic foot ulcers. Efficacy was assessed by time to complete wound healing (by 12 weeks) and incidence of complete wound closure (at 12 weeks). This was an international multi-center, randomized, controlled study. Patients were eligible for entry into the study if the following criteria were met: type 1 or type 2 diabetes mellitus, age 18 to 80 years, adequate glycemic control, and the presence of a full-thickness neuropathic ulcer for at least 2 weeks prior to the initial screening visit. Following the 2-week screening period, the 2 treatment groups received standard ulcer care consistent with international treatment guidelines that comprised sharp debridement, saline-moistened dressings, and a non-weight bearing regimen. There were 106 subjects screened for enrollment, 82 randomized to the treatment groups, and 72 treated (33 Apligraf subjects and 39 standard therapy subjects) before the study was terminated. Kaplan-Meier curves indicated a trend for shorter time to complete wound healing in the Apligraf group compared with the standard therapy group (p = .059; log-rank test). The median time to healing was 84 days in the Apligraf group, whereas no median time to healing could be determined for the standard therapy group because <50% of the standard therapy subjects healed. By 12 weeks, 51.5% (17/33) Apligraf subjects had achieved complete wound closure compared with 26.3% (10/38) of standard therapy subjects (p = .049; Fisher's exact test). Even though the study was halted prematurely, this study suggested that the use of Apligraf resulted in a higher incidence of wound closure by 12 weeks.

Authors+Show Affiliations

Diabetic Foot Clinic, King's College Hospital, Denmark Hill, London, United Kingdom. michael.edmonds@kch.nhs.ukNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19189997

Citation

Edmonds, Michael, and European and Australian Apligraf Diabetic Foot Ulcer Study Group. "Apligraf in the Treatment of Neuropathic Diabetic Foot Ulcers." The International Journal of Lower Extremity Wounds, vol. 8, no. 1, 2009, pp. 11-8.
Edmonds M, European and Australian Apligraf Diabetic Foot Ulcer Study Group. Apligraf in the treatment of neuropathic diabetic foot ulcers. Int J Low Extrem Wounds. 2009;8(1):11-8.
Edmonds, M. (2009). Apligraf in the treatment of neuropathic diabetic foot ulcers. The International Journal of Lower Extremity Wounds, 8(1), pp. 11-8. doi:10.1177/1534734609331597.
Edmonds M, European and Australian Apligraf Diabetic Foot Ulcer Study Group. Apligraf in the Treatment of Neuropathic Diabetic Foot Ulcers. Int J Low Extrem Wounds. 2009;8(1):11-8. PubMed PMID: 19189997.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Apligraf in the treatment of neuropathic diabetic foot ulcers. AU - Edmonds,Michael, AU - ,, Y1 - 2009/02/03/ PY - 2009/2/5/entrez PY - 2009/2/5/pubmed PY - 2009/4/25/medline SP - 11 EP - 8 JF - The international journal of lower extremity wounds JO - Int J Low Extrem Wounds VL - 8 IS - 1 N2 - This study compared the efficacy and safety of Apligraf (Organogenesis, Inc., Canton, MA) in combination with standard therapy versus standard therapy alone in the treatment of neuropathic diabetic foot ulcers. Efficacy was assessed by time to complete wound healing (by 12 weeks) and incidence of complete wound closure (at 12 weeks). This was an international multi-center, randomized, controlled study. Patients were eligible for entry into the study if the following criteria were met: type 1 or type 2 diabetes mellitus, age 18 to 80 years, adequate glycemic control, and the presence of a full-thickness neuropathic ulcer for at least 2 weeks prior to the initial screening visit. Following the 2-week screening period, the 2 treatment groups received standard ulcer care consistent with international treatment guidelines that comprised sharp debridement, saline-moistened dressings, and a non-weight bearing regimen. There were 106 subjects screened for enrollment, 82 randomized to the treatment groups, and 72 treated (33 Apligraf subjects and 39 standard therapy subjects) before the study was terminated. Kaplan-Meier curves indicated a trend for shorter time to complete wound healing in the Apligraf group compared with the standard therapy group (p = .059; log-rank test). The median time to healing was 84 days in the Apligraf group, whereas no median time to healing could be determined for the standard therapy group because <50% of the standard therapy subjects healed. By 12 weeks, 51.5% (17/33) Apligraf subjects had achieved complete wound closure compared with 26.3% (10/38) of standard therapy subjects (p = .049; Fisher's exact test). Even though the study was halted prematurely, this study suggested that the use of Apligraf resulted in a higher incidence of wound closure by 12 weeks. SN - 1534-7346 UR - https://www.unboundmedicine.com/medline/citation/19189997/Apligraf_in_the_treatment_of_neuropathic_diabetic_foot_ulcers_ L2 - http://journals.sagepub.com/doi/full/10.1177/1534734609331597?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -