Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers - Full Text View

Sponsor:	Nanotherapeutics, Inc.
Information provided by (Responsible Party):	Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00764361

Purpose

This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.

Condition	Intervention	Phase
Diabetic Foot Ulcer	Drug: doxycycline Drug: placebo gel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of NanoDOX™ 1.0% Doxycycline Monohydrate Hydrogel in Diabetic Adult Subjects With Lower Extremity Ulcers Compared to Placebo Hydrogel.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Foot Foot Health Leg Injuries and Disorders

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:

Assessment of the safety and efficacy of the topical administration of a 1.0% doxycycline gel (NanoDOX™ Hydrogel) on the healing rates of non-infected diabetic ulcers of the lower extremities when compared with a placebo hydrogel. [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Analyze the molecular changes in pro-inflammatory cytokine levels that occur in diabetic foot ulcers as a function of healing rate in the presence /absence of 1.0% doxycycline. [ Time Frame: baseline, week 4, week 10, week 20 ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	January 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NanoDOX™ Hydrogel 1.0% doxycycline gel	Drug: doxycycline 1.0% doxycycline gel applied topically to the wound once daily for 20 weeks Other Name: doxycycline
Placebo Comparator: Placebo placebo gel	Drug: placebo gel placebo gel applied topically to the wound once daily for 20 weeks Other Name: doxycycline

Detailed Description:

Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association
Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:

• Agree to use a double-barrier method of contraception during their participation in this study;
- condoms (with spermicide) and hormonal contraceptives OR
- condoms (with spermicide) and intrauterine device OR
- intrauterine device and hormonal contraceptives OR
- Abstains from sexual intercourse during their participation in this study OR
- Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening
Be able to apply study drug to their ulcer, or have a caregiver do it
Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg
Target ulcer is Grade I according to the Wagner Grading Scale
Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers
Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers

Exclusion Criteria:

Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
Have more than three chronic ulcers present at baseline
Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
Have connective tissue disease
Currently be going through kidney dialysis for renal failure
Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days
Have participated in another clinical research trial within the last 30 days
Have a known history of osteomyelitis affecting to the area where the target ulcer is present
Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764361

Locations

United States, Florida
North Florida / South Georgia Veterans Administration Hospital
Gainesville, Florida, United States, 32608

Sponsors and Collaborators

Nanotherapeutics, Inc.

Investigators

Study Director:

John Abernethy, MD

Nanotherapeutics, Inc.

More Information

No publications provided

Responsible Party:	Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00764361 History of Changes
Other Study ID Numbers:	2008-DOX-NT/003
Study First Received:	October 1, 2008
Last Updated:	January 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nanotherapeutics, Inc.:

Diabetic
Ulcer
Wound

Additional relevant MeSH terms:

Leg Ulcer
Ulcer
Foot Ulcer
Diabetic Foot
Skin Ulcer
Skin Diseases
Pathologic Processes
Foot Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications

Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012