Study Questions Compression Bandages

Should you use compression bandages to help treat patients with venous leg ulcers? A recent study reveals a downside to using these bandages. Some patients who were treated for venous leg ulcers with compression bandaging developed toe ulcerations and interdigital clefts, according to the study reported in a recent edition of the British Medical Journal. Out of 194 patients being treated for venous leg ulcers with either three- or four-layer compression bandages, the study revealed twelve of the patients developed ulcerations in their toes after being treated for several months with four-layer bandaging. The ulcerations were difficult to heal and reoccurred after several weeks. Patients showed the most improvement after doctors emphasized getting bed rest and elevating the foot, according to the study. One patient’s toes were amputated. “I agree that compression used inappropriately (i.e., arterial vascular disease) can produce ulcerations and even limb loss. If used in the face of congestive heart failure, it can even lead to death,” notes Robert Snyder, DPM. “If (you) use sustained compression in the face of ischemic vascular disease, (you) may encounter gangrene/necrosis when you remove the bandage,” adds Dr. Snyder. He says he does not know if the study will cause podiatrists to re-evaluate their views of compression bandaging, but thinks the study is “a good reminder.” Clinical investigations into the cause of the ulcerations determined the affected patients did not exhibit features of typical ulcerations, such as diabetes mellitus, peripheral neuropathy, arterial insufficiency, musculoskeletal disorders or injury. Patients showed no evidence of fungal infection, viral infection or osteomyelitis and no patients were obese. Researchers of the study say the ulcerations may have been caused by “increased hypoxia in local tissues, marked edema of the toes or development of venous hypertension.” They also point out that biomechanical alterations, caused by four-layer bandaging, could have increased friction and compressed the toes. The ulcerations in the 12 patients were superficial, had no distinct shapes and occurred mostly in the dorsum of three medial toes and interdigital clefts. Researchers noted that all of the affected patients’ toes became distorted after being bandaged. OrCel: A Skin Substitute On The Rise? OrCel, a tissue-engineered skin substitute from Ortec International, seems to be generating quite a bit of momentum. The Centers for Medicare and Medicaid Services (CMS) just approved the modality for inclusion on its Outpatient Prospective Payment System (OPPS) Pass Through List. This allows DPMs at hospitals to get reimbursed when they use OrCel to treat Medicare patients on an outpatient basis. Earlier this year, OrCel won FDA approval for treating epidermolysis bullosa and burn donor site wounds. OrCel is also undergoing a clinical trial for venous leg ulcers and Ortec just announced some promising findings (via interim 12-week clinical data) from a pilot diabetic foot ulcer trial. According to Ortec, the latter trial (involving 40 patients) found 47 percent of the patients treated with OrCel achieved 100 percent wound closure whereas only 23 percent of the control group patients achieved full healing via the standard of care. OrCel is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. Ortec notes these cells secrete a growth factor and cytokines, which normally are found in acute human wounds and are believed to help promote tissue repair. “The preliminary data from the venous leg and diabetic foot ulcer trials is very impressive,” says Scott Lipkin, DPM, who has used OrCel on both types of ulcers in clinical trials. “Healing rates in both trials are similar to those of other bioengineered skin tissues.”