A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX

• Status: Terminated
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Becaplermin; Platelet-derived growth factor BB

Criteria

Inclusion Criteria:

• Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12%

• Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters

• No exposed bone at the ulcer site

• No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure

• Adequate arterial circulation to the foot

• New ulcers must be meet the following criteria: full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure

• Recurrent ulcers must meet the following criteria: stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure

• Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test

Exclusion Criteria:

• Hypersensitivity to REGRANEX® Gel or one of its components

• Presence of more than two full-thickness diabetic ulcers on either lower extremity

• presence of an active systemic or local cancer or tumor of any kind

• Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization

• Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex

• Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation

• Radiation therapy that included the distal lower extremity, at any time in patient's life

• Charcot deformity (rocker bottom foot)