Status:
TERMINATED
Beta Blocker for Chronic Wound Healing
Lead Sponsor:
University of California, Davis
Conditions:
Ulcer
Burns
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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®).
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00368602
Start Date
June 1 2005
End Date
June 1 2007
Last Update
April 7 2015
Active Locations (1)
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1
VA Medical Center
Mather, California, United States, 95655