Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
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| ClinicalTrials.gov Identifier: NCT00316537 |
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Recruitment Status :
Terminated
(Sponsor Decision)
First Posted : April 21, 2006
Last Update Posted : August 9, 2007
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Sponsor:
CoMentis
Information provided by:
CoMentis
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Brief Summary:
The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Foot Ulcers | Drug: ATG002 (study drug) | Phase 1 Phase 2 |
This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. The study will be carried out on a background of conventional wound therapy in patients with Type II diabetes mellitus. Patients will be randomized to receive either study medication (ATG002), vehicle gel, or standard-of-care.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers |
| Study Start Date : | October 2006 |
| Actual Study Completion Date : | July 2007 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Assessment of ulcer size as determined by weekly ulcer tracings
Secondary Outcome Measures :
- Assessment for complete wound closure. "Complete wound closure" will be defined as full epithelialization of the wound with the absence of drainage and lack of dressing requirement for an interval of at least 2 weeks.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with diabetes mellitus type II
- Single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease.
Exclusion Criteria:
- Patients who use tobacco in any form or who are on nicotine replacement therapy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316537
Locations
| United States, Alabama | |
| SeniorCare, Alabama Geriatric Specialists | |
| Homewood, Alabama, United States, 35209 | |
| United States, Arizona | |
| Hope Research Institute | |
| Phoenix, Arizona, United States, 85050 | |
| Southern Arizona VA Health Care System | |
| Tucson, Arizona, United States, 85723 | |
| United States, California | |
| Center for Clinical Research | |
| Castro Valley, California, United States, 94546 | |
| University of San Diego Wound Treatment and Research Center | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Ankle and Foot Specialists of Atlanta | |
| Lithonia, Georgia, United States, 30058 | |
| United States, Maryland | |
| Crossroads Research, Inc. | |
| Owings Mills, Maryland, United States, 21117 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Pennsylvania | |
| NewBridge Medical Research | |
| Warren, Pennsylvania, United States, 16365 | |
| United States, Washington | |
| Central Washington Podiatry Service | |
| Yakima, Washington, United States, 98902 | |
| United States, Wisconsin | |
| Aurora Health Care / Lukes Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
Sponsors and Collaborators
CoMentis
Investigators
| Study Director: | Henry Hsu, MD | Athenagen, Inc. |
| ClinicalTrials.gov Identifier: | NCT00316537 History of Changes |
| Other Study ID Numbers: |
ATG002-121 |
| First Posted: | April 21, 2006 Key Record Dates |
| Last Update Posted: | August 9, 2007 |
| Last Verified: | August 2007 |
Keywords provided by CoMentis:
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diabetes foot ulcers nicotine gel wound healing |
Additional relevant MeSH terms:
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Ulcer Diabetic Foot Foot Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Diabetic Neuropathies Foot Diseases Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |