Beta Blocker for Chronic Wound Healing

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcer, Burns

In brief

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®).

Key facts

Study ID

NCT00368602

Run by

University of California, Davis

People needed

40

Starts

2005-06-01

Expected to finish

2007-06-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• VA Medical Center — Mather, California, United States

Full record on ClinicalTrials.gov

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