Recombinant Human Epidermal Growth Factor in Diabetic Foot Ulcers
Recombinant Human Epidermal Growth Factor in Diabetic Foot Ulcers
A phase III clinical trial was carried out to determine the safety and efficacy of recombinant human epidermal growth factor (rhEGF 150 mg/g; REGEN-D™ 150, Bharat Biotech International Limited, Hyderabad, India) in healing diabetic foot ulcers. The study was a randomized, double-blind, multicenter, parallel study divided into 2 groups. The test group was administered the study drug, and the control group was administered placebo. Skin biopsy was done at baseline and after treatment to evaluate the degree of healing. Parameters, such as increase in collagen tissue, granulation tissue formation, skin epithelization, and microbial growth, were analyzed. The study data was subjected to statistical analysis to determine the significance between the test and the control groups. In the gel-treated group, at the end of 10 weeks, 69% of the ulcers healed, while in the placebo group, only 21% healed in 10 weeks. The study showed that patients with diabetic foot ulcers treated with rhEGF gel had a reduced wound healing time of 9 weeks compared to the patients treated with placebo. The study demonstrated the clinical safety and efficacy of rhEGF in accelerating healing of diabetic foot ulcers.
A skin ulcer occurs when an area of skin has broken down and the underlying tissue can be seen. Most skin ulcers occur on the lower legs or the feet. In a normal person, the skin ulcer heals quickly after the injury. However, in a person with diabetes, the healing process is impaired and takes more time even if the injury is minor.
About 1 in 6 people with diabetes develop a foot ulcer at some stage. Such foot ulcers do not heal easily, are difficult to treat, and are more prone for serious infection. This calls for better treatment methods that address the causative problem instead of offering supportive therapy.
Over the last 10 to 15 years, a large number of trials have been performed to evaluate the safety and efficacy of growth factors in the healing of chronic wounds due to pressure (decubitus ulcers), diabetic neuropathy, and venous insufficiency. The greatest potential for the use of growth factors in chronic wound care is that they can accelerate healing. Growth factors work by binding to specific cell surface receptors and can target cells in a number of recognized ways or modes. After binding to receptors, growth factors can have a profound influence on cell proliferation, chemotactic activity, and extracellular matrix synthesis.
Epidermal growth factor (EGF) belongs to a family of growth factors that regulate cell proliferation, migration, and differentiation through binding to receptor kinases on target cells. Epidermal growth factor has been shown to act as a mitogen and also a differentiation factor for many cell types.
Abstract and Introduction
Abstract
A phase III clinical trial was carried out to determine the safety and efficacy of recombinant human epidermal growth factor (rhEGF 150 mg/g; REGEN-D™ 150, Bharat Biotech International Limited, Hyderabad, India) in healing diabetic foot ulcers. The study was a randomized, double-blind, multicenter, parallel study divided into 2 groups. The test group was administered the study drug, and the control group was administered placebo. Skin biopsy was done at baseline and after treatment to evaluate the degree of healing. Parameters, such as increase in collagen tissue, granulation tissue formation, skin epithelization, and microbial growth, were analyzed. The study data was subjected to statistical analysis to determine the significance between the test and the control groups. In the gel-treated group, at the end of 10 weeks, 69% of the ulcers healed, while in the placebo group, only 21% healed in 10 weeks. The study showed that patients with diabetic foot ulcers treated with rhEGF gel had a reduced wound healing time of 9 weeks compared to the patients treated with placebo. The study demonstrated the clinical safety and efficacy of rhEGF in accelerating healing of diabetic foot ulcers.
Introduction
A skin ulcer occurs when an area of skin has broken down and the underlying tissue can be seen. Most skin ulcers occur on the lower legs or the feet. In a normal person, the skin ulcer heals quickly after the injury. However, in a person with diabetes, the healing process is impaired and takes more time even if the injury is minor.
About 1 in 6 people with diabetes develop a foot ulcer at some stage. Such foot ulcers do not heal easily, are difficult to treat, and are more prone for serious infection. This calls for better treatment methods that address the causative problem instead of offering supportive therapy.
Over the last 10 to 15 years, a large number of trials have been performed to evaluate the safety and efficacy of growth factors in the healing of chronic wounds due to pressure (decubitus ulcers), diabetic neuropathy, and venous insufficiency. The greatest potential for the use of growth factors in chronic wound care is that they can accelerate healing. Growth factors work by binding to specific cell surface receptors and can target cells in a number of recognized ways or modes. After binding to receptors, growth factors can have a profound influence on cell proliferation, chemotactic activity, and extracellular matrix synthesis.
Epidermal growth factor (EGF) belongs to a family of growth factors that regulate cell proliferation, migration, and differentiation through binding to receptor kinases on target cells. Epidermal growth factor has been shown to act as a mitogen and also a differentiation factor for many cell types.
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