MEDICAL DISCLAIMER: Educational research guidelines only. Lyophilized peptides are investigational chemical compounds and are NOT approved for human consumption, diagnosis, or therapy. Consult a licensed physician before any research application.
Becaplermin Dosage Chart, Schedule & Reconstitution Protocol
Quickstart Highlights
Becaplermin (Regranex, rhPDGF-BB) is a recombinant human platelet-derived growth factor-BB supplied as a 0.01% topical gel (100 mcg/g). Applied once daily to a debrided lower-extremity diabetic neuropathic ulcer, it binds PDGF beta-receptors on fibroblasts and other mesenchymal cells to drive chemotaxis, proliferation, collagen and matrix deposition, angiogenesis and granulation-tissue formation, accelerating wound closure [1][6]. In the pivotal phase III trial the 100 mcg/g gel closed 50% of ulcers versus 35% with placebo (PMID 9589248) [2]. The amount applied is calculated from ulcer length x width and recalculated as the wound shrinks, continued up to 20 weeks. Systemic absorption is negligible. It was FDA approved in December 1997; a 2008 boxed warning on cancer mortality was removed in December 2018 after follow-up cohort data found no sustained risk [3][5]. The subcutaneous reconstitution figures on this page are an educational reference only, because Becaplermin is topical and is never injected.
Reconstitute: Add 1.5 mL bacteriostatic water → 1 mg/mL concentration.
Typical dose: 0.01% gel (100 mcg/g), thin layer once daily; ~50-150 mcg delivered per application
Easy measuring: At 1 mg/mL, 1 unit = 0.01 mL = 0.0100 mg (10 mcg) on a U-100 insulin syringe.
Storage: Refrigerate at 2-8 °C; do not freeze. Keep the gel tube tightly capped and protected from heat. In this educational reconstitution model, any reconstituted solution is likewise refrigerated at 2-8 °C and used within about 4 weeks.
Half-life: No clinically meaningful systemic half-life; topical absorption is negligible and circulating PDGF-BB clears within minutes. Dosing is governed by the 12-hour dressing cycle and once-daily application.
Route: Topical 0.01% gel (100 mcg/g) applied once daily to the debrided ulcer; the subcutaneous reconstitution figures here are an educational measurement reference only, not an injection.
Status: FDA approved (December 1997) for diabetic neuropathic foot ulcers; first and only recombinant growth factor approved for a chronic wound. 2008 boxed warning on cancer mortality removed by FDA in December 2018.
About Becaplermin
Becaplermin (brand name Regranex) is recombinant human platelet-derived growth factor-BB (rhPDGF-BB), a homodimeric protein produced in genetically engineered Saccharomyces cerevisiae yeast and formulated as a 0.01% topical gel (100 micrograms per gram) [1][7]. It is the first and, to date, only recombinant growth factor the FDA has approved to treat a chronic wound, specifically lower-extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue and have an adequate blood supply, used alongside (not instead of) sharp debridement, off-loading and infection control [1]. The real-world Becaplermin dosage is topical: a thin continuous bead is squeezed from the tube, spread over the cleaned ulcer once daily, covered with saline-moistened gauze for about 12 hours, then rinsed and re-dressed for the rest of the day [1][4].\n\nBecause this site standardizes every compound as a subcutaneous reconstitution reference, the figures below model a 1.5 mg vial (the becaplermin content of one 15 g 0.01% tube) reconstituted with 1.5 mL of bacteriostatic water, giving 1000 mcg/mL, or 10 mcg per insulin-syringe unit. The modeled \"doses\" (50-150 mcg) approximate the becaplermin mass delivered by a once-daily application sized to a small, medium or large ulcer. This is an educational measurement convention only; clinically, Becaplermin is never injected.\n\nFrequency: Once daily. Apply (clinically) or, in this educational model, dose once every 24 hours, recalculating the amount weekly or biweekly as the ulcer shrinks [1].
Quick Protocol Navigation
Reconstitution Instruction & Mixing Step-by-Step
Lyophilized powder must be reconstituted carefully. Agitating peptide chains can shear disulfide bonds and render the peptide biologically inert.
Draw 1.5 mL of bacteriostatic water into a sterile syringe.
Inject the water slowly down the inner wall of the 1.5 mg Becaplermin vial; do not spray it directly onto the protein powder and do not shake.
Gently swirl or roll the vial until the solution is completely clear; this yields a 1 mg/mL solution (1000 mcg/mL, i.e. 10 mcg per insulin-syringe unit).
Refrigerate at 2-8 °C and draw the modeled dose: 50 mcg = 5 units, 100 mcg = 10 units, 150 mcg = 15 units on a U-100 syringe.
Educational note: clinically Becaplermin is NOT injected. It is squeezed from the tube as a thin 0.01% gel bead, spread over the debrided ulcer once daily, then covered with saline-moistened gauze for about 12 hours; these subcutaneous figures are only a measurement reference.
Interactive Becaplermin Syringe Calculator
Currently visualizing the 1.5 mg vial reconstituted with 1.5 mL bacteriostatic water. Adjust the target dose to dynamically render syringe units.
Reconstitution Calculation: 1.5mg dry powder in 1.5mL water yields 1.00 mg/mL. To evaluate a 250mcg dose, pull to 25.0 units (25 syringe ticks).
U-100 Syringe Representation
Educational reference visual. Assumes standard U-100 insulin syringe where 1.0 mL volume = 100 units.
Titration & Dose Escalation Schedules
| Phase | Dose per injection | Units (per injection) |
|---|---|---|
| Small ulcer (<=2 cm2) - once-daily topical bead | 50 mcg | 5 units (0.05 mL) |
| Medium ulcer (2-5 cm2) - once-daily topical bead | 100 mcg | 10 units (0.10 mL) |
| Large ulcer (>5 cm2) - once-daily topical bead | 150 mcg | 15 units (0.15 mL) |
Administration guidelines: Refer to guidelines | 1.5 mL Reconstitution
Research Supplies Quantity Planner
Scientific mathematical planning of syringes, bacteriostatic water and dry vials needed for extended research blocks using the 1.5 mg vial.
Peptide Vials (Becaplermin, 1.5 mg each):
- checkEach 1.5 mg vial mirrors the becaplermin content of one 15 g 0.01% tube and yields about 15 average (100 mcg) modeled doses.
- checkAbout 4 vials for an 8-week once-daily course (~56 applications).
- checkAbout 6 vials for a 12-week course (~84 applications).
- checkAbout 8 vials for a 16-week course (~112 applications).
Insulin Syringes (U-100):
- checkOne syringe per daily dose: about 56 for an 8-week course.
- checkAbout 84 syringes for a 12-week course.
- checkAbout 112 syringes for a 16-week course.
- check0.5 mL / 31 G U-100 syringes make the 5-15 unit (50-150 mcg) draws easy to read in this educational model.
Bacteriostatic Water (10 mL or 30 mL bottles): Use 1.5 mL per vial for reconstitution.
- check8-week course: about 4 vials x 1.5 mL = ~6 mL.
- check12-week course: about 6 vials x 1.5 mL = ~9 mL.
- check16-week course: about 8 vials x 1.5 mL = ~12 mL.
- checkOne 30 mL bottle covers a full 16-week educational course with margin.
Alcohol Swabs: clean the vial stopper and (in the educational model) the injection site before each use.
- checkAbout 60 swabs for an 8-week course.
- checkAbout 90 swabs for a 12-week course.
- checkAbout 120 swabs for a 16-week course.
- checkA 200-count box covers a full course with margin to spare.
Mechanism of Action (MOA)
Becaplermin is recombinant human platelet-derived growth factor-BB (rhPDGF-BB), a roughly 25 kDa homodimer of two identical B-chains joined by disulfide bonds, produced by inserting the gene for the PDGF B-chain into the yeast Saccharomyces cerevisiae [1][7]. It is biologically equivalent to the endogenous PDGF-BB that platelets release at a site of injury, where PDGF is one of the earliest signals that orchestrates tissue repair.\n\nMechanistically, PDGF-BB binds and dimerizes platelet-derived growth factor receptors (principally PDGFR-beta) on the surface of fibroblasts, smooth-muscle cells and other mesenchymal cells. Receptor autophosphorylation activates PI3K/Akt and MAPK signaling cascades that drive the chemotactic recruitment and proliferation of the cells that rebuild a wound [1][6]. Downstream, becaplermin stimulates fibroblast migration and division, extracellular-matrix and collagen synthesis, conversion of fibroblasts into contractile myofibroblasts, recruitment of inflammatory cells, and angiogenesis, together accelerating formation of granulation tissue and, ultimately, epithelial closure [1][6]. In diabetic wounds, where endogenous growth-factor signaling is blunted and healing stalls, supplying exogenous PDGF-BB helps restart this cascade.\n\nRoute and pharmacokinetics: Becaplermin is applied topically as a 0.01% gel (100 mcg/g). When used on ulcers as directed, systemic absorption is minimal; in pharmacokinetic studies blood PDGF concentrations were non-quantifiable in most subjects, and repeated application does not generate neutralizing antibodies despite the protein's recombinant origin [1][4]. There is therefore no clinically meaningful systemic half-life. Endogenous and recombinant PDGF-BB are cleared from the circulation within minutes, and the gel's effect is local. The dressing strategy mirrors this: the gel is left in contact with the wound under moist gauze for roughly 12 hours, then rinsed off, with a fresh application the next day [1].\n\nDosing logic: because the drug works locally and is dosed to the wound surface, the amount is tied to ulcer area rather than body weight. The prescriber measures the greatest length x greatest width of the ulcer and uses a tube-specific formula (for a 15 g tube, length x width divided by 4 in centimeters, or x 0.6 in inches) to estimate the length of gel to squeeze out; this is recalculated weekly or biweekly as the ulcer changes size [1][4]. Treatment continues until closure or up to 20 weeks; if the ulcer has not decreased by about 30% after 10 weeks, or has not healed by 20 weeks, continued use should be reassessed [1].\n\nThe subcutaneous reconstitution model on this page (a 1.5 mg vial in 1.5 mL of bacteriostatic water, 10 mcg per unit) is purely an educational measurement convention used across this site to express the per-application becaplermin mass; the compound is topical and is never injected subcutaneously [1].
Clinical Trial Efficacy Highlights
- starIn the pivotal phase III randomized, double-blind, placebo-controlled trial, Wieman, Smiell and Su (1998, Diabetes Care) treated chronic neuropathic diabetic foot ulcers and found that becaplermin 100 mcg/g gel increased the incidence of complete wound closure to 50% versus 35% with placebo gel (a 43% relative increase, P = 0.007) and reduced the time to complete closure by 32% (86 vs 127 days, P = 0.013) [2].
- starDose-response in the same program favored the marketed strength: 100 mcg/g produced 50% complete closure compared with 36% for the 30 mcg/g gel and 35% for placebo, which is why 0.01% (100 mcg/g) became the licensed concentration [2][4].
- starThe AAFP STEPS review (2008) summarized that becaplermin, used as an adjunct to good wound care, yields roughly one additional complete closure for every six to seven patients treated (number needed to treat about 6-7), while emphasizing that thorough debridement, off-loading and infection control remain the foundation of therapy [4].
- starMechanistic reviews of growth factors in wound healing confirm that PDGF-BB drives chemotaxis, fibroblast proliferation, extracellular-matrix and collagen deposition, and granulation-tissue formation, providing the biological rationale for topical becaplermin in stalled diabetic wounds [6].
- starZiyadeh and colleagues (2011, Advances in Skin and Wound Care) conducted a matched cohort study of becaplermin users and found no overall increase in cancer incidence (hazard ratio 1.2; 95% CI 0.7-1.9); an early mortality signal in patients with three or more dispensings (rate ratio 5.2 through 2003) was not sustained on extended follow-up through 2006 [3].
- starOn the strength of this and additional large Veterans Affairs database analyses showing no increased cancer or cancer mortality, the FDA approved removal of the becaplermin boxed warning on December 5, 2018 [5].
- starAcross the development program and post-marketing use, systemic absorption of topically applied becaplermin was negligible (blood PDGF non-quantifiable in most subjects) and no neutralizing antibodies developed, supporting a favorable local safety profile [1][4].
- starBecaplermin remains, more than two decades after its December 1997 approval, the first and only recombinant growth factor approved by the FDA for treatment of a chronic wound condition [7].
Side Effects & Tolerability Profile
Clinical subjects transiently report mild side effects. Slowly escalating the titration dose represents the single most effective intervention to limit side effects.
- warningThe most common adverse reaction is an erythematous rash, reported in about 2% of patients, typically at or near the application site [1][4].
- warningLocal application-site reactions reported in post-marketing use include burning sensation, erythema, irritation and localized pain over the treated ulcer [1].
- warningBecaplermin should not be applied to wounds with active infection, and treatment is given only as an adjunct to debridement, off-loading and infection control, not as a substitute for them [1].
- warningIt is contraindicated in patients with known hypersensitivity to becaplermin or any gel component, and in wounds that close by primary intention or have neoplasia at or near the site [1].
- warningHistorically a boxed warning (added 2008) cautioned that use of three or more tubes was associated with increased cancer mortality; that warning was removed by the FDA in December 2018 after long-term cohort data showed no sustained elevated risk, though caution in patients with known malignancy is still reasonable [3][5].
- warningBecause systemic absorption is negligible, systemic adverse effects are not expected with correct topical use; the gel is rinsed off after about 12 hours and is not intended to be left on continuously [1].
- warningThe product is for external topical use only; it is not formulated, dosed or approved for subcutaneous or any injectable administration, and the reconstitution figures on this page are an educational reference, not an injection protocol [1].
- warningRegulatory status: Becaplermin is FDA-approved (December 1997) as a prescription topical gel for diabetic neuropathic foot ulcers; it is not an over-the-counter or research-grade injectable, and any non-topical use described here is purely educational [1][7].
Subcutaneous Injection Technique
Most research peptides require subcutaneous injection into fatty tissue. Never inject directly into a blood vessel or deep muscle tissue unless clinically detailed.
1. Site Selection
Common locations include the abdomen (2 inches from navel), outer upper arms, or thighs.
2. Sanitization
Thoroughly clean the selected site, stopper and vial top using 70% isopropyl alcohol prep swabs.
3. Angle & Push
Pinch the skin and insert the needle at a 45 to 90-degree angle. Depress plunger smoothly.
4. Site Rotation
Rotate injection sites continuously to avoid lipodystrophy or tissue scarring.
Frequently Asked Questions
What is the typical Becaplermin dosage?expand_more
Clinically, Becaplermin is dosed topically, not by a fixed milligram amount. You squeeze a thin continuous bead of the 0.01% gel (100 mcg/g) onto a clean measuring surface and spread it as a thin layer over the entire debrided ulcer once daily, then cover it with saline-moistened gauze for about 12 hours before rinsing. The amount is calculated from the ulcer size: for a 15 g tube, multiply ulcer length by width and divide by 4 (in centimeters) or multiply by 0.6 (in inches) to estimate the length of gel to apply, recalculating weekly or biweekly as the wound shrinks. Treatment continues up to 20 weeks. The 50-150 mcg subcutaneous figures on this page are only an educational measurement model, since one 15 g tube contains just 1.5 mg of becaplermin.
Is Becaplermin FDA approved?expand_more
Yes. Becaplermin (Regranex) was approved by the FDA in December 1997 for lower-extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have adequate blood supply, as an adjunct to good ulcer care. It was the first, and remains the only, recombinant growth factor the FDA has approved to treat a chronic wound. A boxed warning about increased cancer mortality in patients using three or more tubes was added in 2008 and then removed by the FDA in December 2018 after long-term cohort data showed no sustained elevated risk.
How is Becaplermin reconstitution handled?expand_more
Becaplermin is supplied as a ready-to-use gel and is not actually reconstituted in clinical practice. The reconstitution steps on this page are an educational convention used across the site: we model a 1.5 mg vial (the becaplermin content of one 15 g 0.01% tube) dissolved in 1.5 mL of bacteriostatic water to give 1000 mcg/mL, or 10 mcg per U-100 insulin-syringe unit, so the per-application mass can be expressed in familiar units. This is a measurement reference only; the real product is a topical gel that is never injected.
What is Becaplermin's half-life?expand_more
Because topical Becaplermin has negligible systemic absorption (blood PDGF levels were non-quantifiable in most subjects in pharmacokinetic studies), it does not have a clinically meaningful systemic half-life. Circulating PDGF-BB is cleared within minutes, and the gel acts locally at the wound. In practice the dosing interval is governed by the dressing routine: the gel is left on the ulcer under moist gauze for about 12 hours, rinsed off, and a fresh dose is applied once every 24 hours.
How is Becaplermin administered, and can it be injected?expand_more
Becaplermin is administered topically only. The gel is applied once daily as a thin layer over the cleaned, debrided ulcer using a clean cotton swab or applicator, covered with a saline-moistened dressing for roughly 12 hours, then rinsed and re-dressed with non-medicated gauze for the rest of the day. It is not formulated or approved for subcutaneous or any injectable use. The injection-style figures here exist solely to fit the site's standardized reconstitution format and should not be interpreted as an injection protocol.
Related Guides & Tools
Step-by-step references for reconstituting, measuring, and storing Becaplermin, plus the universal dosing calculator.
Academic References & Study Citations
REGRANEX (becaplermin) Gel 0.01% - FDA prescribing information (DailyMed label): indications, dosage and administration, mechanism, pharmacokinetics, warnings and storage. View Scientific Paper →
Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers: a phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998;21(5):822-827. View Scientific Paper →
Ziyadeh N, Fife D, Walker AM, Wilkinson GS, Seeger JD. A matched cohort study of the risk of cancer in users of becaplermin. Adv Skin Wound Care. 2011;24(1):31-39. View Scientific Paper →
Becaplermin (Regranex) for Diabetic Foot Ulcers. STEPS review, American Family Physician (AAFP). 2008;78(2):255-256. View Scientific Paper →
Smith & Nephew / FDA. FDA approves removal of boxed warning from REGRANEX (becaplermin) gel, December 5, 2018. View Scientific Paper →
Barrientos S, Brem H, Stojadinovic O, Tomic-Canic M. Clinical application of growth factors and cytokines in wound healing (review of PDGF-BB / becaplermin mechanism). PMC4812574. View Scientific Paper →
Why Are There So Few FDA-Approved Therapeutics for Wound Healing? (review noting becaplermin/rhPDGF-BB approved 1997 as the first and only recombinant growth factor for chronic wounds). PMC10606455. View Scientific Paper →