Beta Blocker for Chronic Wound Healing

Study Overview
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Brief Summary
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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®).

Detailed Description
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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

Official Title
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Beta Adrenergic Receptor Modulation of Burn Wound Healing

Conditions
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Burns, Ulcer

Intervention / Treatment
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* Drug: Timoptic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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): 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care. | Drug: Timoptic<br>* Timoptic to be applied to the target wound daily for up to 12 weeks.<br>* Other names: beta adrenergic antagonists;|
| Placebo Comparator: 2<br>The group will be given standard of care with placebo medication. | Other: Placebo<br>* Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100% re-epithelialization will be clinically determined at each visit by the Investigator. |  | 12 weeks |