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Trade names | Regranex |
AHFS/Drugs.com | Consumer Drug Information |
MedlinePlus | a699049 |
Routes of administration | Topical |
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Becaplermin, sold under the brand name Regranex, is a cicatrizant, available as a topical gel. Regranex is a human platelet-derived growth factor indicated along with good wound care for the treatment of lower extremity diabetic neuropathic ulcers. [1] It is also known as "platelet-derived growth factor BB". [1]
Becaplermin is used for the treatment of diabetic foot ulcers. [2] Studies of becaplermin showed that when used with good wound care, complete healing significantly increased and the ulcers healed on average 6 weeks faster. [3] Pharmacoeconomic studies reinforce the cost effectiveness of becaplermin as an adjunct to good wound care. [4]
The amount of becaplermin to be applied will vary depending upon the size of the ulcer area. Becaplermin should be stored in the refrigerator. [1] Analysis of healing human wounds showed that PDGF-BB induces fibroblast proliferation and differentiation and was found to increase healing in patients with decreased healing capacity, such as people living with diabetes. [5]
Becaplermin must not be used at the site of a skin cancer. [6]
The most common side effects in clinical studies were erythematous rashes. [6]
A boxed warning has been added to the US FDA prescription label to describe an increase rate of death from cancer when three or more tubes are used. [7]
An ulcer is a sore on the skin or a mucous membrane, accompanied by the disintegration of tissue. Ulcers can result in complete loss of the epidermis and often portions of the dermis and even subcutaneous fat. Ulcers are most common on the skin of the lower extremities and in the gastrointestinal tract. An ulcer that appears on the skin is often visible as an inflamed tissue with an area of reddened skin. A skin ulcer is often visible in the event of exposure to heat or cold, irritation, or a problem with blood circulation.
A wound is any disruption of or damage to living tissue, such as skin, mucous membranes, or organs. Wounds can either be the sudden result of direct trauma, or can develop slowly over time due to underlying disease processes such as diabetes mellitus, venous/arterial insufficiency, or immunologic disease. Wounds can vary greatly in their appearance depending on wound location, injury mechanism, depth of injury, timing of onset, and wound sterility, among other factors. Treatment strategies for wounds will vary based on the classification of the wound, therefore it is essential that wounds be thoroughly evaluated by a healthcare professional for proper management. In normal physiology, all wounds will undergo a series of steps collectively known as the wound healing process, which include hemostasis, inflammation, proliferation, and tissue remodeling. Age, tissue oxygenation, stress, underlying medical conditions, and certain medications are just a few of the many factors known to affect the rate of wound healing.
Diabetic neuropathy includes various types of nerve damage associated with diabetes mellitus. The most common form, diabetic peripheral neuropathy, affects 30% of all diabetic patients. Symptoms depend on the site of nerve damage and can include motor changes such as weakness; sensory symptoms such as numbness, tingling, or pain; or autonomic changes such as urinary symptoms. These changes are thought to result from a microvascular injury involving small blood vessels that supply nerves. Relatively common conditions which may be associated with diabetic neuropathy include distal symmetric polyneuropathy; third, fourth, or sixth cranial nerve palsy; mononeuropathy; mononeuropathy multiplex; diabetic amyotrophy; and autonomic neuropathy.
Pressure ulcers, also known as pressure sores, bed sores or pressure injuries, are localised damage to the skin and/or underlying tissue that usually occur over a bony prominence as a result of usually long-term pressure, or pressure in combination with shear or friction. The most common sites are the skin overlying the sacrum, coccyx, heels, and hips, though other sites can be affected, such as the elbows, knees, ankles, back of shoulders, or the back of the cranium.
Platelet-derived growth factor (PDGF) is one among numerous growth factors that regulate cell growth and division. In particular, PDGF plays a significant role in blood vessel formation, the growth of blood vessels from already-existing blood vessel tissue, mitogenesis, i.e. proliferation, of mesenchymal cells such as fibroblasts, osteoblasts, tenocytes, vascular smooth muscle cells and mesenchymal stem cells as well as chemotaxis, the directed migration, of mesenchymal cells. Platelet-derived growth factor is a dimeric glycoprotein that can be composed of two A subunits (PDGF-AA), two B subunits (PDGF-BB), or one of each (PDGF-AB).
Epidermal growth factor (EGF) is a protein that stimulates cell growth and differentiation by binding to its receptor, EGFR. Human EGF is 6-kDa and has 53 amino acid residues and three intramolecular disulfide bonds.
Neuropathic arthropathy refers to a progressive fragmentation of bones and joints in the presence of neuropathy. It can occur in any joint where denervation is present, although it most frequently presents in the foot and ankle. It follows an episodic pattern of early inflammation followed by periarticular destruction, bony coalescence, and finally bony remodeling. This can lead to considerable deformity and morbidity, including limb instability, ulceration, infection, and amputation.
Maggot therapy is a type of biotherapy involving the introduction of live, disinfected maggots into non-healing skin and soft-tissue wounds of a human or other animal for the purpose of cleaning out the necrotic (dead) tissue within a wound (debridement), and disinfection.
Venous ulcer is defined by the American Venous Forum as "a full-thickness defect of skin, most frequently in the ankle region, that fails to heal spontaneously and is sustained by chronic venous disease, based on venous duplex ultrasound testing." Venous ulcers are wounds that are thought to occur due to improper functioning of venous valves, usually of the legs. They are an important cause of chronic wounds, affecting 1% of the population. Venous ulcers develop mostly along the medial distal leg, and can be painful with negative effects on quality of life.
A chronic wound is a wound that does not heal in an orderly set of stages and in a predictable amount of time the way most wounds do; wounds that do not heal within three months are often considered chronic. Chronic wounds seem to be detained in one or more of the phases of wound healing. For example, chronic wounds often remain in the inflammatory stage for too long. To overcome that stage and jump-start the healing process, a number of factors need to be addressed such as bacterial burden, necrotic tissue, and moisture balance of the whole wound. In acute wounds, there is a precise balance between production and degradation of molecules such as collagen; in chronic wounds this balance is lost and degradation plays too large a role.
Negative-pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC), is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burns. The therapy involves the controlled application of sub-atmospheric pressure to the local wound environment using a sealed wound dressing connected to a vacuum pump. The use of this technique in wound management started in the 1990s and this technique is often recommended for treatment of a range of wounds including dehisced surgical wounds, closed surgical wounds, open abdominal wounds, open fractures, pressure injuries or pressure ulcers, diabetic foot ulcers, venous insufficiency ulcers, some types of skin grafts, burns, sternal wounds. It may also be considered after a clean surgery in a person who is obese.
Platelet-rich plasma (PRP), also known as autologous conditioned plasma, is a concentrate of plasma protein derived from whole blood, centrifuged to remove red blood cells but retaining platelets. Though promoted for treating various medical conditions, evidence of its benefits was mixed as of 2020, showing effectiveness in certain conditions and ineffectiveness in others.
Arterial insufficiency ulcers are mostly located on the lateral surface of the ankle or the distal digits. They are commonly caused by peripheral artery disease (PAD).
Transdermal Continuous Oxygen Therapy is a wound closure technique for chronic and acute wounds which blankets a wound in oxygen on a 24-hour basis until the wound heals. Unlike hyperbaric oxygen treatment for chronic wounds, oxygen treatment used in this therapy is not systemic in nature and treats only the wound area. This treatment differs from topical oxygen treatments, as topical oxygen typically involves sporadic treatments of 1–3 hours several times per week, while TCOT treatment is 24/7 by nature.
The dermal equivalent, also known as dermal replacement or neodermis, is an in vitro model of the dermal layer of skin. There is no specific way of forming a dermal equivalent, however the first dermal equivalent was constructed by seeding dermal fibroblasts into a collagen gel. This gel may then be allowed to contract as a model of wound contraction. This collagen gel contraction assay may be used to screen for treatments which promote or inhibit contraction and thus affect the development of a scar. Other cell types may be incorporated into the dermal equivalent to increase the complexity of the model. For example, keratinocytes may be seeded on the surface to create a skin equivalent, or macrophages may be incorporated to model the inflammatory phase of wound healing.
A diabetic foot disease is any condition that results directly from peripheral artery disease (PAD) or sensory neuropathy affecting the feet of people living with diabetes. Diabetic foot conditions can be acute or chronic complications of diabetes. Presence of several characteristic diabetic foot pathologies such as infection, diabetic foot ulcer and neuropathic osteoarthropathy is called diabetic foot syndrome. The resulting bone deformity is known as Charcot foot.
Chronic wound pain is a condition described as unremitting, disabling, and recalcitrant pain experienced by individuals with various types of chronic wounds. Chronic wounds such as venous leg ulcers, arterial ulcers, diabetic foot ulcers, pressure ulcers, and malignant wounds can have an enormous impact on an individual’s quality of life with pain being one of the most distressing symptoms.
Diabetic foot ulcer is a breakdown of the skin and sometimes deeper tissues of the foot that leads to sore formation. It is thought to occur due to abnormal pressure or mechanical stress chronically applied to the foot, usually with concomitant predisposing conditions such as peripheral sensory neuropathy, peripheral motor neuropathy, autonomic neuropathy or peripheral arterial disease. It is a major complication of diabetes mellitus, and it is a type of diabetic foot disease. Secondary complications to the ulcer, such as infection of the skin or subcutaneous tissue, bone infection, gangrene or sepsis are possible, often leading to amputation.
Total contact casting (TCC) is a specially designed cast designed to take weight off of the foot (off-loading) in patients with diabetic foot ulcers (DFUs). Reducing pressure on the wound by taking weight off the foot has proven to be very effective in DFU treatment. DFUs are a major factor leading to lower leg amputations among the diabetic population in the US with 85% of amputations in diabetics being preceded by a DFU. Furthermore, the five-year post-amputation mortality rate among diabetics is estimated at 45% for those with neuropathic DFUs.
Nepidermin, also known as recombinant human epidermal growth factor (rhEGF), is a recombinant form of human epidermal growth factor (EGF) and a cicatrizant. As a recombinant form of EGF, nepidermin is an agonist of the epidermal growth factor receptor (EGFR), and is the first EGFR agonist to be marketed. It was developed by Cuban Center for Genetic Engineering and Biotechnology (CIBG), and has been marketed by Heber Biotech as an intralesional injection for diabetic foot ulcer under the trade name Heberprot-P since 2006. As of 2016, Heberprot-P had been marketed in 23 countries, but remains unavailable in the United States. In 2015, preparations were made to conduct the Phase III trials required for FDA approval, however as of 2023 developments in U.S.-Cuba relations have stymied importation of the drug from Cuba.
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