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Beta Blocker for Chronic Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368602
Recruitment Status : Terminated (Lack of funding.)
First Posted : August 25, 2006
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcer Burns Drug: Timoptic Other: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Beta Adrenergic Receptor Modulation of Burn Wound Healing
Study Start Date : June 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 100% re-epithelialization will be clinically determined at each visit by the Investigator. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00368602

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United States, California
VA Medical Center
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Rivkah R Isseroff, MD University of California, Davis
Additional Information:
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Responsible Party: University of California, Davis Identifier: NCT00368602    
Other Study ID Numbers: 05-06-00351
First Posted: August 25, 2006    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents