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Beta Blocker for Chronic Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00368602
Recruitment Status : Terminated (Lack of funding.)
First Posted : August 25, 2006
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE August 24, 2006
First Posted Date  ICMJE August 25, 2006
Last Update Posted Date April 7, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2006)
The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing.
Change History Complete list of historical versions of study NCT00368602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
100% re-epithelialization will be clinically determined at each visit by the Investigator. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2006)
100% re-epithelialization will be clinically determined at each visit by the Investigator.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Beta Blocker for Chronic Wound Healing
Official Title  ICMJE Beta Adrenergic Receptor Modulation of Burn Wound Healing
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 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
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcer
  • Burns
Intervention  ICMJE
  • Drug: Timoptic
    Timoptic to be applied to the target wound daily for up to 12 weeks.
    Other Name: beta adrenergic antagonists
  • Other: Placebo
    Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.
Study Arms
  • Experimental: 1
    This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care.
    Intervention: Drug: Timoptic
  • Placebo Comparator: 2
    The group will be given standard of care with placebo medication.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 24, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00368602
Other Study ID Numbers  ICMJE 05-06-00351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rivkah R Isseroff, MD University of California, Davis
PRS Account University of California, Davis
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP