Recombinant Human Platelet-Derived Growth Factor (rhPDGF-BB)

Becaplermin (Recombinant PDGF — Chronic Wounds)

Brand names: Regranex

A recombinant human platelet-derived growth factor (PDGF) topical gel used to promote granulation and healing of chronic lower-limb diabetic neuropathic ulcers as an adjunct to standard wound care.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Amount applied depends on ulcer size. Measure the greatest length by the greatest width of the ulcer, then calculate the length of gel from a 15 g tube: INCHES = ulcer length x ulcer width x 0.6; CENTIMETRES = ulcer length x ulcer width / 4. Each square inch of ulcer surface requires approximately a 2/3 inch length of gel; each square centimetre requires approximately a 0.25 cm length of gel. Worked examples from the label: an ulcer measuring 1 inch by 2 inches needs a 1 1/4 inch length of gel (1 x 2 x 0.6); an ulcer measuring 4 cm by 2 cm needs a 2 cm length of gel ((4 x 2) / 4).

Route: Topical, to the cleaned ulcer. For topical use only — not for oral, ophthalmic or intravaginal use.

Frequency: Once daily, until complete healing has occurred.

Gel strength 0.01%. Application method: squeeze the calculated length of gel onto a clean measuring surface (e.g. wax paper) and measure it to the correct length with a ruler; transfer it using an application aid and spread over the entire cleaned ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. Cover the application site with a saline-moistened gauze dressing and leave in place for approximately 12 hours; then remove the dressing, rinse the ulcer with saline or water to remove residual gel, and cover again with a moist primary dressing (without gel) for the remainder of the day. Recalculate the amount to be applied at weekly or biweekly intervals depending on the rate of change in ulcer area. Reassess continued treatment if the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment, or if complete healing has not occurred in 20 weeks. Gel weight from a 15 g tube is 0.65 g per inch length and 0.25 g per centimetre length. Step-by-step home-care application instructions are in the FDA-approved Instructions for Use. NO UK SPC (eMC) RECORD was present in the source bundle — this draft is from US prescribing information (REGRANEX Gel 0.01%, LRM Therapeutics, label date 2026-05-08) and must be verified against current UK labelling and availability. The bundle did not include the label's indications section, so the licensed wound type should be confirmed before this is presented as a chronic-wound dose; the dosing text itself refers generically to 'the ulcer'. No paediatric dosing statement was present in the fetched sections. The adverse reactions section was truncated at the source-fetch limit.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known neoplasm(s) at the site(s) of application

Side effects

Erythematous rashes — occurred in 2% of patients treated (the same rate as placebo with good ulcer care in clinical trials)
Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use (Warnings 5.1)
In a retrospective follow-up study of 491 subjects, cancers were diagnosed in 8 of 291 (2.7%) becaplermin-treated subjects versus 2 of 200 (1%) vehicle/standard-of-care subjects — relative risk 2.7 (95% CI 0.6-12.8)
Application site reactions — consider the possibility of sensitisation or irritation caused by the parabens or m-cresol excipients, and consider interruption or discontinuation and further evaluation, e.g. patch testing (Warnings 5.2)
Subjects treated with becaplermin did not develop neutralizing antibodies against becaplermin

Interactions

It is not known whether becaplermin interacts with other topical medications applied to the ulcer site; use with other topical drugs has not been studied

Clinical monograph

How it works

Becaplermin is biologically equivalent to endogenous PDGF and stimulates chemotaxis and proliferation of cells involved in wound repair, promoting granulation tissue formation.

Prescribing in practice

An increased rate of secondary-malignancy mortality has been reported with repeated tubes, so it is contraindicated in known neoplasia and should be used cautiously with careful patient selection.
It is an adjunct only and does not replace debridement, infection control and pressure offloading.
Apply to clean, adequately debrided, well-perfused wounds and discontinue if there is no healing response within a reasonable period.

Monitoring

Monitor wound size and granulation at regular dressing changes and reassess the appropriateness of continued therapy.

Counselling the patient

Apply a thin layer over the ulcer as directed and cover with a moist dressing.
Continue good foot care, offloading and glucose control.
Tell your clinician about any history of cancer before using this gel.

Evidence & guidelines

Becaplermin is licensed as an adjunct for diabetic neuropathic ulcers, with a safety warning regarding malignancy with repeated use.

Reference: MHRA Drug Safety Update 2008 (cancer risk); Regranex SPC; NICE Diabetic Foot Ulcer Guidelines NG19; Bhansali et al. Wound Repair Regen 2009; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators