The purpose of this study is to evaluate the efficacy and safety of Regranex Gel versus placebo when applied to recurring or non-healing neuropathic diabetic lower extremity ulcers for up to 52 consecutive weeks including an initial treatment period of up to 20 weeks with Regranex Gel or for up to two retreatment episodes.

Condition	Treatment or Intervention	Phase
Diabetic Foot Ulcers	Drug: Regranex Gel  Drug: Placebo	Phase III

Further Study Details: 

Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Male or female, aged 18 to 80 years, inclusive
• Diabetes mellitus Type I or Type II and a glycohemoglobin A1c<12%
• A 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.
• Subjects must be willing to: Comply with study gel application and dressing change instructions; remain non-weightbearing and/or prevent rubbing (shear injury) on the treated ulcer site(s) for the duration of the study; adhere to the study requirements or have adequate caretaker assistance;
• Adequate arterial circulation to the foot evidenced by palpable ankle pulses or other acceptable noninvasive vascular testing.
• 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 (hormonal or IUD)for at least 1 month prior to study entry and throughout the study; maintained her normal menstrual pattern within thre months prior to study entry; have a negative serum pregnancy test prior to study entry, at the start of ulcer treatment, and at the end of the study.

Exclusion Criteria

• Female subjects who are pregnant or wish to be pregnant within the next 5 years or breast feeding mothers.
• Hypersensitivity to REGRANEX® Gel or one of its components.
• Presence of more than two full-thickness diabetic ulcers on either lower extremity.
• The 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.
• Life expectancy less than 3 years.
• Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of REGRANEX.
• End stage renal failure (ESRF) necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis (CAPD).
• A chronic alcohol, psychiatric condition or drug abuse problem, as determined from medical history, which the investigator feels, may pose a threat to subject compliance.
• Subject received systemic corticosteroid maintenance therapy (equivalent to >10 mg/day of prednisone), 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.
• Subject received radiation therapy which included the distal lower extremity, at any time in subject?s life.
• A Charcot deformity (rocker bottom foot).

California
      VA Medical Center, Long Beach,  California,  90822,  United States
Rhode Island
      Roger Williams Medical Center, Providence,  Rhode Island,  02908,  United States
South Carolina
      Palmetto Richland Memorial Hospital, Columbia,  South Carolina,  29203,  United States
Virginia
      Columbia Retreat Hospital, Richmond,  Virginia,  23220,  United States

Study ID Numbers:  PDGF-DBFT-027(INT-9)
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034788
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08