Fetal Bovine Collagen and Human Amniotic Tissue Allograft Application and Effect on Healing of Venous Leg Ulcers

Background: Venous leg ulcers affect 2.2 million Americans annually. These wounds can be the source of major distress for patients due to pain, infection, and impaired quality of life. Generally, these patients are treated with compression therapy as it allows patients to improve venous return and increases the likelihood of better wound healing by reducing venous edema, promoting oxygenation in the surrounding dermal tissue, and stimulating fibrinolysis. However, for some patients, compression therapy alone is not sufficient; they need adjunctive treatment in order to achieve complete wound closure. Placental allograft membrane is a tri-layer allograft consisting of amnion-chorion-amnion layers containing extracellular matrix, cytokines, and growth factors to promote wound healing.

Methods: 5 patients with venous leg ulcers present for longer that 4 weeks and less than 2 years were selected to participate in this study. Each patient was treated for 4 weeks with fetal bovine collagen and was seen in clinic each week to monitor progress. Wound debridement was completed at the discretion of the clinician. Following 4 weeks of treatment with fetal bovine collagen, patients were treated weekly with placental allograft membrane for 8 weeks. Wound progress was monitored subjectively by the clinician and eKare was utilized to provide accurate and consistent objective wound measurements.

Primary endpoints were: VLU closure rate after 12 total weeks of treatment. Secondary endpoints were: number of patients with closed wounds and percentage area reduction of VLUs.

Results: Treatment was generally well-tolerated by patients with no increase in pain from baseline reported by any of the patients for the duration of the treatment period. 2/5 patients achieved complete wound closure. The average wound area reduction was 6.1 cm and average wound area reduction percentage of 43%.

Conclusion: Patients responded favorably to placental allograft membrane, as there was a weekly appreciable decrease in wound area observed during the treatment period. The product was well tolerated and did not cause any additional discomfort for the patients. The wound area reduction percentage was impressive and makes it a viable option in the treatment of venous leg ulcers.