Beta Blocker for Chronic Wound Healing

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Adrenergic Agents; Adrenergic Antagonists; Adrenergic beta-Antagonists; Timolol

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