|
Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo Clinical research trials and Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo. Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo clinical trial. Test subjects typically receive the most effective healthcare possible for their Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "L" Clinical Trials Conditions > Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo  Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo
Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo
For Condition: Diabetic Foot Ulcers
Status: Terminated
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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).
Total Enrollment: 200
Location and Contact Information:
Roger Williams Medical Center
Providence, Rhode Island, 02908
United States
Columbia Retreat Hospital
Richmond, Virginia, 23220
United States
Palmetto Richland Memorial Hospital
Columbia, South Carolina, 29203
United States
VA Medical Center
Long Beach, California, 90822
United States
Additional Information:
Study ID Numbers: PDGF-DBFT-027(INT-9);
Study Start Date: January 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034788
Other Diabetic Foot Ulcers Studies:
1. Clinical Trials of Footwear in Patients with Diabetes-Study Arm 2,3
2. A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
3. Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo
4. Gene Therapy to Improve Wound Healing in Patients With Diabetes
5. Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing
Related Studies:
Other Diabetic Foot Ulcers Clinical Trials
Other South Carolina Clinical Trials
Other Columbia Clinical Trials
Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers with Regranex or Placebo
|
|
|
|
|
|
|
|
