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

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 short- age impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most diffi cult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and con- tours 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 extracel- lular 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 infi ltration; evi- dence 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 infi ltration of this product can enhance heal- ing of chronic wounds safely and effi caciously. 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 recal- citrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favor- able risk-benefi t ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment world- wide of Heberprot-P would provide an opportunity to assess the prod- uct's potential to address an important unmet medical need.