Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00764361
First received: October 1, 2008
Last updated: March 8, 2012
Last verified: March 2012
  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 2

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™ Hydrogel(1.0% Doxycycline Monohydrate)in Diabetic Adult Subjects With Lower Extremity Ulcers Compared to Placebo Hydrogel.

Resource links provided by NLM:


Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:
  • Number of Participants Without Adverse Events [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
    Participants were monitored for 20 weeks during the study.


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 NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel) [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: February 24, 2012
Last Updated: March 8, 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 July 29, 2014