Beta Blocker for Chronic Wound Healing

NCT00368602 | Terminated Phase 2

• 1 other identifier: 05-06-00351
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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®).

Conditions

Ulcer; Burns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 100% re-epithelialization will be clinically determined at each visit by the Investigator.

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care.

Drug: Timoptic

2

PLACEBO COMPARATOR

The group will be given standard of care with placebo medication.

Other: Placebo

Interventions

Timoptic DRUG

Timoptic to be applied to the target wound daily for up to 12 weeks.

Also known as: beta adrenergic antagonists

1

Placebo OTHER

Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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):
• 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;

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

VA Medical Center

Mather, California, 95655, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Ulcer; Burns

Interventions

Timolol; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Rivkah R Isseroff, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 25, 2006
• Study Start: June 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)