beta blocker for chronic wound healing

Conditions: Ulcer; Burns

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®).

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 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