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
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: 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:
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014