Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034788
Status:
TERMINATED
Last Update Posted:
2011-06-08
First Post:
2002-05-02
Brief Title:
A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Clinical Evaluation of the Efficacy and Safety of REGRANEX Gel in the Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment Study did not address safety concern raised by European Medicines Agency
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of REGRANEXÂ 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
Detailed Description:
This study has an initial open-label treatment period of up to 20 weeks with REGRANEX gel for ulcers of the ankle or foot related to diabetes mellitus Gel is applied once a day in a thin layer to cover the entire surface of the ulcer then a non-adherent dressing and gauze are used to cover the gel If all ulcers are healed during this open-label period and if they remain healed after 24 weeks of observation the patient discontinues the study If one or more ulcers are not healed during the 20 weeks of if an ulcer recurs or a new ulcer is observed during up to 24 weeks of observation then the patient enters Double-blind Phase 1 during which neither the patient nor the physician knows whether the study drug or placebo is being applied to the ulcer This Phase 1 may continue for up to 52 weeks If one or more ulcers are not healed during 52 weeks of treatment the patient discontinues the study If all ulcers are healed during this phase and if they remain healed after 24 weeks of observation the patient discontinues the study If an ulcer recurs or a new ulcer is observed during the observation period following Phase 1 treatment then the patient enters Double-blind Phase 2 of the study for up to 20 weeks If the ulcer is healed during Phase 2 treatment the patient discontinues from the study at that time If the ulcer remains unhealed after 20 weeks of Phase 2 the study is stopped Efficacy assessments include the time to complete healing of the ulcer the incidence of complete ulcer healing and the reduction in total ulcer area at the end of the study Safety assessments include the incidence of adverse events throughout the study changes in clinical laboratory tests hematology chemistry urinalysis measurement of vital signs at specified intervals and physical examinations at the start and end of the study The study hypothesis is that the time to complete healing of diabetic foot ulcers with continued treatment using REGRANEX is shorter than the time to healing with placebo and that the patients will well tolerate the medication REGRANEX gel or placebo applied to cover the entire surface of the ulcer once a day for up to 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None