Objectives: To explore whether Heberprot-P an epidermal growth factor is a cost-effective option for the treatment of advanced diabetic foot ulcer as an add-on therapy to good wound care GWC in Slovakia from the perspective of health care payers. The week clinical trial period was extended to 5- and year time horizons. Transition probabilities were calculated based on a previous clinical trial of Heberprot, utility values were derived from the scientific literature, and cost vectors were collected from the General Health Insurance Fund database in Slovakia. A one-way deterministic sensitivity analysis was employed to explore the influence of uncertainty for each input parameter on the incremental cost-effectiveness ratio ICER. The ICER increases if a longer time horizon is applied, as the incremental costs are similar, but the aggregated utility gain from avoided amputation is lower. Conclusions: Heberprot-P, as an add-on therapy to GWC in the treatment of advanced diabetic foot ulcer, is not a cost-effective alternative to GWC alone.
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Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation.
Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations.
Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in , and in was included in the National Basic Medications List and approved for marketing.
It has been registered in 15 other countries, enabling treatment of more than , patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk.
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Create a file for external citation management software Create file Cancel. Full-text links Cite Favorites. Abstract Diabetic foot ulcer is a principal diabetic complication. PMID: Intralesional administration of epidermal growth factor-based formulation Heberprot-P in chronic diabetic foot ulcer: treatment up to complete wound closure. Int Wound J. Part one. Montequin JF, et al. Angiol Sosud Khir. Growth factors for treating diabetic foot ulcers.
Cochrane Database Syst Rev. PMID: Review. Epidermal growth factor in the treatment of diabetic foot ulcers: an update. Tiaka EK, et al.
Perspect Vasc Surg Endovasc Ther. Epub Apr Show more similar articles See all similar articles. Rev Panam Salud Publica. Olivieri B, et al. Semin Intervent Radiol. Epub Feb 5. Therapeutic strategies for enhancing angiogenesis in wound healing. Veith AP, et al. Adv Drug Deliv Rev. Epub Sep Tesar T, et al. Front Pharmacol. Garcia Herrera AL, et al. Curr Ther Res Clin Exp. Show more "Cited by" articles See all "Cited by" articles. MeSH terms Amputation Actions. Clinical Trials as Topic Actions.
Cuba Actions. Humans Actions. Severity of Illness Index Actions. Substances Recombinant Proteins Actions. Epidermal Growth Factor Actions. Copy Download.
Heberprot-P: A Novel Product for Treating Advanced Diabetic Foot Ulcer
Recently, several ulcers have appeared on his foot, putting it at risk of being amputated. However, this has not happened, thanks to a unique Cuban product Heberprot-P, a drug that has sparked acclaim for its effectiveness in controlling and healing diabetic foot ulcers. A few weeks ago, Navarro was admitted at Havana's Institute of Angiology and Vascular Surgery, a medical institution where comprehensive treatment is given to patients suffering from chronic diabetes. The doctors applied Heberprot-P and I could see the substantial improvement in just 20 days. Since then I was discharged and my ulcer is almost closed," the man told Xinhua. This drug registered in was created by Cuban scientist Jorge Berlanga and a team from the Center for Genetic Engineering and Biotechnology of the island. It contains epithermal growth factor EGF as an active pharmaceutical ingredient, while being applied by direct infiltration or injections in the wound site closing the ulcers in a period of 45 to 90 days.
Symptoms and Rating
Diabetes is no longer considered life threatening, nonetheless diabetes and complications due to diabetes, when not under control, remain to be sixth leading cause of death having a higher mortality rate than some cancers such as prostate cancer, breast cancer and colon cancer. Diabetic foot ulcer occurs when an ulcer or a wound develop in an area in the lower legs or feet which do not heal or are difficult to treat leading to the exposure of the underlying tissue and becoming susceptible to infections.. It is not uncommon for people with diabetes to have diabetic foot ulcers for some time without being aware of the development. Some of the symptoms to look for include:. Due to nerve damage and loss of sensations and the ability to feel pain, foot damage, even from such simple things as pressure from shoes or a small cut, go unnoticed and unprotected resulting in worsening skin loss, blisters and a possibility of a serious infection than may progress in a matter of days.