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

NCT00034788 | Terminated Phase 3

• 1 other identifier: CR003238
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Foot Ulcer; Diabetic Foot; Skin Ulcer; Diabetic Neuropathies

Keywords

Regranex; Foot ulcers; Diabetes; Diabetes mellitus; Diabetic foot

Outcome Measures

Primary Outcomes (1)

• Time to complete ulcer healing.

Secondary Outcomes (1)

• Incidence of complete ulcer healing and reduction in total ulcer area at end of study. Incidence of adverse events throughout study.

Interventions

Becaplermin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo

MeSH Terms

Conditions

Foot Ulcer; Diabetic Foot; Skin Ulcer; Diabetic Neuropathies; Diabetes Mellitus

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: December 1, 2000
• Study Completion: February 1, 2004
• Last Updated: June 8, 2011

Record last verified: 2010-03