Status:
COMPLETED
Beta Adrenergic Antagonist for the Healing of Chronic DFU
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
VA Northern California Health Care System
Conditions:
Chronic Diabetic Foot Ulcers
Diabetic Neuropathic Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic ulcers are very challenging to manage and are the most common cause of leg amputation. Many advanced treat...
Detailed Description
The trial is designed as a prospective, randomized, double-blinded controlled study of subjects presenting with diabetic foot ulcers. The purpose of this study is to evaluate the superiority of Timopt...
Eligibility Criteria
Inclusion
- Male or female subject of any race 18 years old or older
- Lower extremity ulcer located anywhere on the foot (as defined as beginning below the malleoli of the ankle):
- Of more than 30 days duration and less than 2 years duration
- Surface area between 0.5cm2 and 20cm2 (as measured with the Silhouette imaging system at randomization). The ulcer with largest surface area meeting inclusion criteria will be selected as index ulcer
- If two ulcers present with the same surface area, the ulcer of the longest duration will be selected as index ulcer
- Documented Ankle Brachial Index (ABI) between 0.8 and 1.2 on the study limb or toe pressure over 65mmHg within 3 months of screening phase
- Documented biopsy report to rule out malignancy of ulcer of \> 6 months duration
- Subject or legally authorized representative understands and is willing to give written informed consent
- Subject or legally authorized representative is willing and able to comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization and to comply with all study requirements
Exclusion
- Ulcer of non-diabetic etiology, such as venous, arterial and burn wounds
- Index ulcer is less than 3 cm in distance from any other ulcer on the same extremity
- There are greater than 3 ulcers on the study foot
- Index ulcer presents with any of the following: cellulitis, osteomyelitis, exposed bone, tendon or fascia, capsule , purulent exudate or gangrene
- Index ulcer shows evidence of infection (defined as a moderate or severe rating of all of the following clinical signs/symptoms:
- increased warmth
- increased pain
- erythema
- malodorous exudate at Screening or at Randomization (Visit 1), OR total organism count \> 1 x 105 colony forming units (CFU) from the screening visit study ulcer culture sample)
- Index ulcer surface area has decreased or increased \> 40% between Screening and at Randomization (Visit 1) as assessed by the Silhouette imaging system
- Has acquired or is known to be infected with Human Immunodeficiency Virus (HIV)
- Has active malignancy on the study foot
- Has uncontrolled diabetes mellitus as defined by glycosylated hemoglobin A1C \> 12%
- Has immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal
- Has severe protein malnutrition as defined by serum albumin \< 2.5 g/dL
- Has serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal
- Has fatigue, palpitations, dyspnea, and/or angina at rest
- Has a history, within the previous 12 months from date of Screening Visit, of alcohol or drug abuse, particularly methadone or heroin
- Has received previous treatment with the following during the 60 days prior to Screening:
- Immunosuppressive agents
- radiation
- chemotherapy
- growth factors (epidermal growth factor, tumor necrosis factor, transforming growth factor, platelet derived growth factor, etc.)
- at the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active (or engineered) cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
- Has been hospitalized for treatment of a diabetic foot ulcer within the previous 30 days from Screening
- Has history of heart block 2nd and 3rd degree
- Female who is pregnant or refuses to use adequate contraceptive methods and is of childbearing age during the trial
- Prisoners, institutionalized individuals or vulnerable population
Key Trial Info
Start Date :
July 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03282981
Start Date
July 24 2018
End Date
April 30 2024
Last Update
May 8 2025
Active Locations (1)
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1
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655-4200