Edmonds M, European and Australian Apligraf Diabetic Foot Ulcer Study Group., et al.
The international journal of lower extremity wounds. Date of publication 2009 Mar 1;volume 8(1):11-8.
1. Int J Low Extrem Wounds. 2009 Mar;8(1):11-8. doi: 10.1177/1534734609331597. Epub
2009 Feb 3.
Apligraf in the treatment of neuropathic diabetic foot ulcers.
Edmonds M(1); European and Australian Apligraf Diabetic Foot Ulcer Study Group.
Collaborators: Adner N, Gerok-Andersson K, Brismar K, Bryson P, Dobozy A, Dumont
I, Edmonds M, Feuerstein P, Gough S, Harding K, Higgs ER, Hunyadi J, Jones GR,
Kerr D, Martini D, Chauchard MC, Mischer P, O'Malley B, Rayman G, Richard JL,
Jourdan N, Shearman C, Vaalasti A, Van Acker K, Vowden P, Yue D.
Author information:
(1)Diabetic Foot Clinic, King's College Hospital, Denmark Hill, London, United
Kingdom. michael.edmonds@kch.nhs.uk
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.
DOI: 10.1177/1534734609331597
PMID: 19189997 [Indexed for MEDLINE]
