- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03282981
Beta Adrenergic Antagonist for the Healing of Chronic DFU (BAART-DFU)
Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95655-4200
- VA Northern California Health Care System, Mather, CA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Timolol
Timoptic-XE plus standard of care (SOC)
|
Topical application of Timolol on non-healing diabetic foot ulcers
Other Names:
|
Placebo Comparator: SOC plus non biologically active gel
SOC plus non biologically active gel (hydrogel as placebo medication)
|
Topical application of non biologically active gel (Hydrogel- standard of care) on non-healing diabetic foot ulcers
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete wound closure, as assessed over a 12 week period
Time Frame: 12 weeks
|
Complete wound closure will be assessed by Investigators and is defined as 100% epithelialization of the wound site ("skin re-epithelialization without drainage or dressing requirements by Week 12).
|
12 weeks
|
Measurement of timolol serum during the treatment phase
Time Frame: 31 weeks
|
Primary safety outcome
|
31 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time to wound closure between the two groups
Time Frame: 31 weeks
|
31 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sara E. Dahle, DPM MPH, VA Northern California Health Care System, Mather, CA
- Principal Investigator: Rivkah R. Isseroff, MD, VA Northern California Health Care System, Mather, CA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
Other Study ID Numbers
- SURG-004-16F
- 17-08-00792 (Other Grant/Funding Number: VA Northern California Health Care System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Diabetic Foot Ulcers
-
Biotec Pharmacon ASACompletedChronic Diabetic Foot UlcersUnited Kingdom
-
Tissue Regeneration TechnologiesUnknownChronic Diabetic Foot UlcersUnited States
-
SerenaGroup, Inc.Tides MedicalRecruitingChronic Diabetic Foot UlcersUnited States, Puerto Rico
-
Medical University of ViennaVienna University of TechnologyCompletedChronic Diabetic Foot UlcersAustria
-
Oneness Biotech Co., Ltd.RecruitingChronic Diabetic Foot UlcersUnited States
-
Osiris TherapeuticsTerminatedChronic Diabetic Foot UlcersUnited States
-
3MWithdrawnDiabetic Foot Ulcers | Venous Stasis Ulcers | Pressure Ulcers | Trauma Wounds | Acute and Chronic WoundsUnited States
-
Indiana UniversityNational Institute of Nursing Research (NINR)RecruitingDiabetic Foot Ulcers | Burn Wound | Wound | Chronic Wound | Pressure Ulcers | Venous Leg Ulcers | ChronicUnited States
-
Technical University of MunichWithdrawn
-
CytomedixCTI Clinical Trial and Consulting ServicesTerminatedDiabetic Foot Ulcers | Wounds | Pressure Ulcers | Leg UlcersUnited States
Clinical Trials on Timolol
-
Laboratoires TheaCompletedOcular Hypertension GlaucomaBulgaria
-
Fraser HealthWithdrawnIschemic Optic Neuropathy | Optic Neuropathy, Ischemic | Anterior Ischemic Optic Neuropathy | Optic Neuropathy, Anterior IschemicCanada
-
ForSight Vision5, Inc.CompletedOcular Hypertension | Open-Angle GlaucomaPanama
-
Vistakon PharmaceuticalsCompletedOcular Hypertension | Glaucoma, Open AngleUnited States
-
Afyon Kocatepe University HospitalCompleted
-
Vistakon PharmaceuticalsCompletedOcular Hypertension | Open-angle GlaucomaUnited States
-
Medical University of ViennaCompleted
-
Alcon ResearchCompletedOcular Hypertension | Open-Angle Glaucoma
-
Santen OyCompletedOcular Hypertension | Open-angle GlaucomaHungary
-
Aristotle University Of ThessalonikiCompleted