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A review of a bi-layered living cell treatment (Apligraf) in the treatment of venous leg ulcers and diabetic foot ulcers.
Zaulyanov L, Kirsner RS. Clin Interv Aging. 2007;2(1):93-8.
Quote:
Apligraf (Organogenesis, Canton, MA) is a bi-layered bioengineered skin substitute and was the first engineered skin US Food and Drug Administration (FDA)-approved to promote the healing of ulcers that have failed standard wound care. Constructed by culturing human foreskin-derived neonatal fibroblasts in a bovine type I collagen matrix over which human foreskin-derived neonatal epidermal keratinocytes are then cultured and allowed to stratify, Apligraf provides both cells and matrix for the nonhealing wound. Its exact mechanism of action is not known, but it is known to produce cytokines and growth factors similar to healthy human skin. Initially approved by the FDA in 1998 for the treatment of venous ulcers greater than one-month duration that have not adequately responded to conventional therapy, Apligraf later received approval in 2000 for treatment of diabetic foot ulcers of greater than three weeks duration. Herein, we review the use of Apligraf in the treatment of chronic venous leg ulcers and diabetic foot ulcers. Our goal is to provide a working understanding of appropriate patient selection and proper use of the product for any physician treating this segment of the aging population.
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 multicenter, 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. At 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 at 12 weeks.
I have used Apligraf and a similar product, Dermagraf, on slow-healing diabetic ulcers. I recommend them both, as long as the vascular status of the patient supports healing, and pressure to the wound can be temporarily eliminated.
The problem we find is that the graft must be ordered carefully. It is made to order, and it is very expensive. Nearly all cases around our area are done in hospital surgery centers or outpatient surgery centers, because most practitioners cannot afford to buy the material, risking unforseen complications or cancellations.
I have used Apligraf for other wounds, as well. These include venous stasis ulcers, burn injuries, and a case of sickle cell ulcers which was unresponsive to HBO, traditional wound care, etc.
How is your patient doing, Dr. Footwound??
-John
__________________
Dr. John G. Fasick
LSUHSC New Orleans
Clinical Insructor, LSU School of Medicine jfasic@lsuhsc.edu
Apligraf Treatment
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