epidermal-growth-factor and Varicose-Ulcer

A great deal of interest has been focused recently on the potential use of synthetic polypeptide growth factors to stimulate healing of chronic wounds. In this pilot double-blind randomized study conducted at a single center, we used human recombinant epidermal growth factor (h-EGF) to treat 44 patients with venous ulceration of the lower extremities. An aqueous solution (10 micrograms/mL) of h-EGF was applied topically to the ulcers twice a day until healing occurred or for a maximum of 10 weeks. Patients were evaluated weekly for measurements of ulcer size and for the formation of granulation tissue suitable for grafting. Nine patients were excluded from efficacy evaluation because of protocol violations. Therefore, 35 patients (17 h-EGF, 18 placebo) were evaluable for efficacy, and 44 patients (22 h-EGF, 22 placebo) were available for safety. The median baseline ulcer size for all patients was 18.5 cm2, and was not significantly different between h-EGF and placebo group (12.9 cm2 versus 19.2 cm2, respectively, P = .27). By study end, six (35%) of h-EGF treated patients and two (11%) in the placebo group had healed completely (P = .10). Another 6 patients (2 of 17 h-EGF, 4 of 18 placebo; P = .50) developed healthy granulation tissue that was suitable for grafting. The median ulcer size reduction was 7% for h-EGF versus 3% for placebo per week (P = .29), and 73% versus 33% at study end (P = .32). No untoward side effects were related to the application of h-EGF. We conclude that topical application of h-EGF, in the dose and manner used in this study, was safe but failed to significantly enhance re-epithelialization of venous ulcers. However, a greater reduction in ulcer size and a larger number of healed ulcers with the use of h-EGF are encouraging results.

Topics: Administration, Topical; Bandages; Double-Blind Method; Drug Evaluation; Epidermal Growth Factor; Female; Humans; Male; Middle Aged; Recombinant Proteins; Varicose Ulcer; Wound Healing

Venous ulcers are the terminal phase of chronic venous insufficiency, the result of induced skin disorders and maintained by persistent venous hypertension. Affecting a large part of the adult population, they drain economic resources and greatly impact patient quality of life.. The objective of this descriptive, retrospective case series was to determine the efficacy of recombinant human epidermal growth factor (rhEGF) plus compression therapy vs standard of care in 48 patients with active ulcers resulting from chronic venous insufficiency.. In this descriptive, retrospective case series, 24 patients (mean age, 62.4 years) received rhEGF by intralesional and perilesional infiltration with compression therapy, and 24 patients (mean age, 69.4 years) received treatment with topical hydrocolloid gels and compression therapy. In 62.5% of patients, the ulcers were located in the internal malleoli. Ulcer progression time, ulcer size, Wollina score index, number of conventional cures, rhEGF vials used, and time to epithelialization were documented.. Epithelialization of the active ulcer was reached in 100% of intervened patients. In the 24 patients receiving rhEGF, 71% achieved wound closure in 8 weeks or less, and the remaining percentage achieved closure within 9 and 12 weeks. In the conventional therapy group, patients achieved closure in an average of 29.5 weeks, with a minimum of 13 weeks and a maximum of 46 weeks.. Although conventional therapy with the use of hydrocolloids and compression achieved adequate epithelialization of venous ulcers, the use of rhEGF significantly decreased healing time and could be a beneficial therapy to these patients who have few therapeutic options.

Topics: Adult; Aged; Epidermal Growth Factor; Humans; Middle Aged; Quality of Life; Retrospective Studies; Varicose Ulcer; Wound Healing

To evaluate the efficacy, tolerability, and safety of a novel wound dressing containing epidermal growth factor (EGF) in a collagen-gel matrix on hard-to-heal venous leg ulcers.. The authors included 33 hard-to-heal venous leg ulcers found on 31 patients. The EGF-containing dressing was applied 3 times while best practice conservative wound treatment was continued. Patients were followed up with after 1, 2, and 3 months to evaluate (a) the wound size, (b) the ease of application and dissolution of the dressing, and (c) the wound dressing by means of a scale ranging from 1 to 5 (1 = best, 5 = worst).. The protocol was completed by 25 of 31 patients. The reasons for discontinuation were wound infection, pain, and lost to follow-up (n = 2 each, respectively). After 3 months, the average wound surface was significantly reduced (from 33.69 cm to 18.94 cm, P = .023). On a scale from 0 to 100, the wound dressing was evaluated as very easy to apply and highly dissolvable (mean value of 97.14 and 98.11, respectively; 100 = very easy to apply or 100% dissolution). The dressing was generally well tolerated and scored a mean overall rating of 2.16 by healthcare specialists and 2.40 by patients.. The authors' results demonstrate that the novel EGF-containing wound dressing was generally well tolerated and safe. Combined with the significant wound surface reduction, it can be regarded as an adequate novel treatment option for patients with hard-to-heal venous leg ulcers.

Topics: Adult; Aged; Aged, 80 and over; Bandages, Hydrocolloid; Collagen; Epidermal Growth Factor; Female; Humans; Male; Middle Aged; Treatment Outcome; Varicose Ulcer; Wound Healing