Beta Blocker for Chronic Wound Healing

This study has been terminated.
(Lack of funding.)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368602
First received: August 24, 2006
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).


Condition Intervention Phase
Ulcer
Burns
Drug: Timoptic
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Beta Adrenergic Receptor Modulation of Burn Wound Healing

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 100% re-epithelialization will be clinically determined at each visit by the Investigator. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care.
Drug: Timoptic
Timoptic to be applied to the target wound daily for up to 12 weeks.
Other Name: beta adrenergic antagonists
Placebo Comparator: 2
The group will be given standard of care with placebo medication.
Other: Placebo
Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.

Detailed Description:

The purpose of this study is to learn more about how to heal venous leg ulcers faster and to test the safety of a drug and see what effects it has on a venous leg ulcer.

You will:

  • be interviewed and examined
  • have a physical exam
  • have blood and urine tested
  • have photographs taken of the wound
  • apply medication to the leg ulcer as directed
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any race btwn 18 and 85 years of age, inclusive;
  • Male or female, neither pregnant nor lactating.
  • Informed consent;
  • Have at least 1 lower extremity ulcer in the gaiter area (knee to ankle):

    1. Surface area of ≥2 sq. cm. to ≤20 sq. cm.; Ulcer with largest surface area meeting inclusion criteria will be selected.
    2. If 2 ulcers present with the same surface area, ulcer of longest duration selected.
    3. Study ulcer must be at least 2 cm from any other ulcer on same extremity.
    4. A viable wound bed free of necrotic tissue post-debridement, if debridement is indicated.

      5. Have an Ankle Brachial Index (ABI) >0.7; 6. Presence of either dorsalis pedis or posterior tibialis pulses by Doppler on the study extremity; 7. Have a non-healing (open) ulcer for at least 1 month. Subjects who failed conservative therapy are eligible for the study; 8. Comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization; 9. Two or more of the following: dermatitis, atrophie blanche, varicosities, hyperpigmentation or lipodermatosclerosis;

      Exclusion Criteria:

  • Decrease in wound surface area of >35% btwn Screening and Visit 1 (Randomization);
  • Cellulitis, osteomyelitis, ulcer with exposed bone, tendon or fascia, or purulent exudates in ulcer area;
  • Grade IV ulcer;
  • Evidence of study ulcer infection;
  • Study ulcer of non-venous etiology;
  • Acquired or are known to be infected with HIV;
  • Uncontrolled diabetes mellitus;
  • Immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal;
  • Severe protein malnutrition as defined by serum albumin <2.5 g/dL;
  • Severe anemia defined as a total of hemoglobin of <10 g/dL for males or <8 g/dL for females;
  • Chronic renal insufficiency requiring dialysis;
  • Serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal;
  • New York Heart Association Functional Classification of IV;
  • Deep vein thrombosis (DVT) w/in last 6 weeks or clinical evidence of current DVT;
  • Arterial revascularization of the study extremity w/in previous 6 months from the date of Screening Visit;
  • History, w/in previous 12 months from date of Screen Visit, of alcohol or drug abuse, particularly methadone or heroin;
  • Received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
  • Received previous treatment with systemic corticosteroids prior to Screening (Chronic corticosteroids w/in 90 days or short course corticosteroids w/in 30 days)
  • Been hospitalized for treatment of any venous ulcer w/in the previous 30 days from Screening.
  • Asthma or a history of asthma, obstructive pulmonary disease, myasthenia gravis, hyperthyroidism, history of heart block
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368602

Locations
United States, California
VA Medical Center
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Rivkah R Isseroff, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Rivkah Isseroff, M.D., UC Davis
ClinicalTrials.gov Identifier: NCT00368602     History of Changes
Other Study ID Numbers: 05-06-00351
Study First Received: August 24, 2006
Last Updated: May 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Burns
Ulcer
Wounds and Injuries
Pathologic Processes
Adrenergic Agents
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 17, 2014