Diabetic Ulcers Heal Faster if Skin Substitute Applied Weekly

Kathleen Louden

May 12, 2014

Almost twice as many persistent diabetic foot ulcers that underwent allografting with dehydrated human amnion/chorion membrane (EpiFix, MiMedx Group, Marietta, Georgia) completely healed, on average, with a weekly application vs once every other week, according to the results of new small trial.

More frequent grafting not only healed the chronic ulcers 1.7 weeks more quickly than biweekly application, it did so without significantly increasing the number and cost of grafts, according to study coauthor Robert J. Snyder, DPM, from Barry University School of Podiatric Medicine, Miami Shores, Florida.

"Results were really dramatic in the group of patients receiving the weekly application," Dr. Snyder told Medscape Medical News. "At the end of 4 weeks, 90% of wounds receiving weekly grafts healed vs 50% in the biweekly group."

"There are very few treatments on the market that come close to this healing of diabetic foot ulcers," said Dr. Snyder, who is a consultant to the product's manufacturer, which funded the study.

Potential to Improve Patient Satisfaction

The new findings were presented last month in a poster at the Symposium on Advanced Wound Care (SAWC) Spring in Orlando, Florida and were published in the April issue of the International Wound Journal.

The results seem encouraging, said Windy Cole, DPM, a wound-care specialist in private podiatric practice in Cleveland, Ohio, who did not participate in the study.

"Although 1.7 weeks [faster healing] may not seem like a lot, it may make all the difference to the patient," Dr. Cole said in an interview with Medscape Medical News.

"These wounds have a high incidence of infection, and quicker healing translates to a happier patient," she added.

Small Single-Center Trial

The comparative, parallel-group, single-center trial reported by Dr Snyder enrolled 40 patients with noninfected diabetic foot ulcers that had lasted for 4 weeks or longer and had failed to heal by 20% with conventional treatment. All patients underwent grafting with the dehydrated form of the amnion/chorion membrane, which is obtained from human donors' placenta after screening and testing for infectious diseases.

Twenty patients each were randomly assigned to receive allografts either once weekly or every 2 weeks. All wounds were offloaded with a removable cast walker.

There are very few treatments on the market that come close to this healing of diabetic foot ulcers.

At study entry, the only significantly different clinical characteristic between groups was a higher mean hemoglobin A1c concentration in the weekly group (8.7% vs 7.3%; P = .036).

The primary outcome was the mean time to complete reepithelialization of the wound without drainage or the need for a dressing.

Wounds that received weekly grafts healed completely in an average of 2.4 ± 1.8 weeks compared with 4.1 ± 2.9 weeks in the biweekly group, a significant difference (P = .039).

Number and Percentage of Diabetic Foot Ulcers Completely Healed

Weeks of Treatment Biweekly Allografts (n = 20) Weekly Allografts (n = 20) P
2 4 (20) 13 (65) .009
4 10 (50) 18 (90) .014
6 14 (70) 19 (95) .091
8 15 (75) 20 (100) NA
12 17 (85) 20 (100) NA
NA = not available (not calculated)

Similar Number of Grafts in Both Groups

Each group received a similar number of grafts on each healed wound by the end of the 12-week study, the data show. The weekly group received 2.3 ± 1.8 grafts, and the biweekly group had 2.4 ± 1.5 grafts.

Dr. Snyder explained that the number of grafts was similar because the patients in the weekly group healed more quickly. They also needed smaller pieces of graft tissue, which kept costs comparable between groups, he added.

An advantage of this product, according to Dr. Snyder, is its availability in various sizes, from 1.5 sq cm and up, which decreases waste when the wound is small.

Dr. Cole agreed this is a benefit, saying, "EpiFix is the new kid on the block. It is as effective, if not more effective, than comparable products but is significantly less costly than other skin substitutes such as Apligraf [Organogenesis, Canton, Massachusetts] because of its long shelf life and multiple sizes."

The dehydrated product can be stored at room temperature for up to 5 years, the manufacturer says.

EpiFix Should Not Be Last Resort

"We want to give patients the latest and greatest in advanced wound healing, but our hands are being tied due to reduced Medicare reimbursement," Dr. Cole observed. "Because EpiFix costs less, we will be able to provide this product and still be a profitable center. That's huge."

She believes that the application frequency of this amniotic membrane allograft should be left to physician choice.

EpiFix, which became available in the United States in 2011, is considered a tissue product and is not regulated as a medical device, according to MiMedx.

Dr. Snyder said the small sample size was a limitation of his study, as was the lack of a standard-care control group. However, he said the results show it is time for practitioners to rethink the indications for this product.

"Many clinicians use EpiFix as a last resort, and that is not the way this product is designed to be used. It should be used if there is not 50% improvement in healing after 4 weeks of standard treatment," he said.

The study was funded by MiMedx, the maker of EpiFix, which had no control over the study. Dr. Snyder has disclosed that he is a consultant to MiMedx but reports no other relevant financial relationships. Dr. Cole reported no relevant financial relationships.

Int Wound J. 2014;11:122-128. Article


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