OrCelTM, a wound dressing used to stimulate wound closure and repair and regenerate skin, is being studied as a potential treatment for diabetic foot ulcers. Results from a pilot trial were published earlier this year in the journal Wounds, and showed that hard-to-heal ulcers treated with OrCel healed faster and more completely than similar ulcers treated with the current standard of care. The trial studied forty patients whose ulcers didn’t respond to standard treatment within two weeks. Twenty were treated with OrCel dressing for six weeks followed by standard care for six weeks, while the other twenty received only the current standard of care for all twelve weeks.
The results of the study showed that ulcers less than 6 square centimeters in size were approximately twice as likely to completely heal when treated with OrCel as when treated with the current standard of care. In the twelve week trial, seven of the twenty ulcers treated with OrCel were completely healed, while only four of the twenty ulcers in the control group were completely healed. In addition, the rate of wound closure was higher and the daily healing rate was faster for patients treated with OrCel.
OrCel is a biologically active collagen sponge with human skin cells in it. It is applied as a 2"x2" patch directly on a skin wound. It received FDA approval in 2001 to treat two conditions: dystrophic epidermolysis bullosa, a rare skin condition in children, and wounds resulting from skin grafts for serious burns. It is now being studied for other wounds, including diabetic foot ulcers and venous stasis ulcers.
Unlike many other skin treatments that replace only the epidermal (outer) or the dermal (inner) layer of skin, OrCel is considered "composite cultured skin" and is intended to heal both layers. Although OrCel and other similar skin treatments are often called "skin substitutes," they are not intended to fully replace skin. OrCel is missing many of the types of cells that make up skin, including the cells that provide pigment and protection against infection. It is derived from neonatal human foreskin cells.
Because this treatment is still in development, it is not yet available to most patients.
Foot ulcers are a major problem for people with diabetes. Because diabetes can cause patients to lose feeling in the nerve endings in their feet, wounds may go unnoticed. About 800,000 people are treated for diabetic foot ulcers each year, and one in seven people with diabetes will get a foot ulcer in his or her lifetime. If foot ulcers are left untreated, amputation may become necessary. Diabetics should examine their feet daily for callouses, scrapes, or other problems and seek medical advice if any occur.