Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
CoDa Therapeutics Inc. |
---|---|
Information provided by: | CoDa Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT00820703 |
Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes. New treatments that improve the number of ulcers that heal and/or speed up healing are urgently needed. Initial studies with a new drug called Nexagon® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic foot ulcers can be improved with topical application of Nexagon®. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to diabetic foot ulcers at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the toss of a coin) 24 people with diabetic foot ulcers to Nexagon® (one of three different doses) or vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed over four weeks to monitor their response to the treatment, specifically with regards to the amount of healing that occurs.
Condition | Intervention | Phase |
---|---|---|
Diabetic Foot Ulcer |
Drug: Nexagon® Drug: Nexagon® vehicle |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Prospective, Double-Blind, Vehicle-Controlled, Dose-Escalation, Single-Center Study of the Safety and Clinical Effect of Nexagon® in the Treatment of Participants With Diabetic Foot Ulcers |
Estimated Enrollment: | 24 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ajith Dissanayake | (09) 276 0000 | Ajith.Dissanayake@middlemore.co.nz |
Contact: Ravi Subramanian | (09) 276 0000 | Ravi.Subramaniam@middlemore.co.nz |
New Zealand | |
Middlemore Hospital | |
Auckland, New Zealand |
Responsible Party: | CoDa Therapeutics ( Scott Bannan ) |
Study ID Numbers: | NEX-ULC-003 |
Study First Received: | January 8, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00820703 |
Health Authority: | New Zealand: Medsafe |
Nexagon CoDa ulcer diabetic foot |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Foot Diseases Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |