Regranex Logo
For US Healthcare Professionals only.


An increased rate of mortality secondary to malignancy was
observed in patients treated with 3 or more tubes of REGRANEX® Gel
in a postmarketing retrospective cohort study. View More.


regranex, regranex gel, case studies, diabetic foot ulcer, diabetic foot ulcer case study, regranex case study, regranex gel case study

Select a picture to enlarge.

Patient description

60-year-old female with uncontrolled type 2 diabetes (HbA1c–12.0%), peripheral neuropathy, and peripheral artery disease (PAD). Using silver sulfadiazine cream and gauze bandage for left foot ulcer that developed as "insect bite" in February 2012. Fully ambulatory in post-op shoes. Intermittent sharp pain in left foot.

Wound presentation

Patient presented on March 23, 2012 with full-thickness ulcer, measuring 3.2 cm x 3.2 cm x 1.7 cm, on left lateral foot over the 5th metatarsal base.

Vascular exam revealed left femoral bruit. Left dorsalis pedis (DP) and popliteal pulses nonpalpable and monophasic with Doppler. Angiogram demonstrated widely patent left common, internal, and external iliac arteries; very mild PAD in left common and superficial femoral artery; 40% focal stenosis of left popliteal artery; occlusion of left anterior tibial artery; left DP filled via collaterals; extensive calcific plaque in peroneal artery with diffuse narrowing; extensive calcific plaque in post-tibial artery.


On April 9, patient underwent left popliteal to DP artery bypass using in situ greater saphenous vein conduit. Left lateral foot wound was surgically debrided. On April 16, negative pressure wound therapy was started. On May 21, full-thickness skin graft was applied to ulcer. On June 8, skin graft failure was noted. Ultrasound demonstrated occulsion of bypass graft. Ulcer was sharp debrided and enzymatically debrided with Collagenase SANTYL® Ointment 250 units/g, ADAPTIC®, and gauze.
On June 21, treatment started with hyperbarics (adequate blood supply to the wound was confirmed); enzymatic debridement with SANTYL® Ointment was continued. On July 13, wound was sharp debrided and hyperbarics continued, and treatment was started with REGRANEX® (becaplermin) Gel, 0.01%; SANTYL® Ointment was discontinued. On August 10, hyperbaric treatment was completed and treatment with REGRANEX® Gel continued for another 8 1/2 weeks. Ulcer was completely healed on
October 8, 2012.

*Individual results will vary.

Case studies contributed by Susie Seaman, NP, MSN, CWOCN.

Adaptic is a registered trademark of Systagenix Wound Management. Santyl is a registered
trademark of Smith & Nephew, Inc.



An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX® Gel in a postmarketing retrospective cohort study. REGRANEX® Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX® Gel should be used with caution in patients with known malignancy.

Indication and limitations of use

REGRANEX® (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. REGRANEX® Gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

  • The efficacy of REGRANEX® Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.
  • The effects of REGRANEX® Gel on exposed joints, tendons, ligaments, and bone have not been established in humans.
  • REGRANEX® Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.


REGRANEX® Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application. REGRANEX® Gel is contraindicated in patients with known hypersensitivity to any component of the product (e.g., parabens).

Warnings and precautions

Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. REGRANEX® Gel should be used with caution in patients with a known malignancy.

If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered.

Commonly observed adverse reactions

In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX® Gel (and good ulcer care) or placebo (and good ulcer care), and none in patients receiving good ulcer care alone.

See warnings above regarding malignancy.

Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX® Gel.

Other important information

The amount of REGRANEX® Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending upon the rate of change in ulcer area.

If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX® Gel should be reassessed.

Pregnancy & Nursing Mothers: Pregnancy Category C. REGRANEX® Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REGRANEX® Gel is administered to nursing women.

Safety and effectiveness of REGRANEX® Gel in pediatric patients below the age of 16 years have not been established.

Counsel patients to review the Medication Guide and to discuss any questions or concerns with their healthcare provider before starting REGRANEX® Gel and at regular intervals during treatment, including when their prescription is refilled.

To report suspected adverse reactions, contact Smith & Nephew at 1-800-441-8227 or contact FDA at or at 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Medication Guide.

This information is intended for healthcare professionals in the United States and is not intended for the general public.