Heberprot-P: a novel product for treating advanced diabetic foot ulcer

Abstract

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 2006, and in 2007 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 100,000 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. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product's potential to address an important unmet medical need.

Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials

“…EGF has been shown to stimulate epidermal and dermal repair in animal wound models . Deep injection of EGF into the ulcer stimulates the production of extracellular matrix proteins thereby enhancing cell proliferation and migration . A meta‐analysis specifically evaluating the effects of rhEGF in DFU corroborated with the findings of the present network meta‐analysis .…”

Systemic translation of locally infiltrated epidermal growth factor in diabetic lower extremity wounds

“…Patients received 75 μg of EGF at each intralesional infiltration session, three times per week on alternate days. The medication, its administration requisites, and procedure have been extensively described …”

The Use of a Mixture of Hypericum Perforatum and Azadirachta indica for the Management of Diabetic Foot Ulcers: A Case Series

“…A large cohort study has shown that the use of lipid lowering medications reduces the risk of lower extremity amputations by 35-43% [25]. The use of Hydrogel dressings has been found having significantly greater effect on ulcer healing than larval therapy or platelet-derived growth factors [26] as some other treatments are under evaluation [27][28][29][30][31][32][33][34]. Because of these literature data showing results less satisfactory than the ones we observed while using Hyperoil ™ , we're continuing to use Hyperoil ™ for the treatment of diabetic foot ulcers in WCU, to understand its possible use in earlier stages of the disease, too.…”