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Beta Adrenergic Antagonist for the Healing of Chronic DFU (BAART-DFU)

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ClinicalTrials.gov Identifier: NCT03282981
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
VA Northern California Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

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 treatments are expensive and difficult to use in the clinic or at home. Those newer therapies have shown little success in healing diabetic foot wounds. The investigators' laboratory and animal work has suggested that a safe medication, currently used as an eye drop for treatment of glaucoma, can heal these ulcers. The investigators are proposing to test this drop (timolol) directly on the surface of the foot ulcer to see if can improve healing faster than the current standard of care. To do this, the investigators propose a "randomized controlled trial" with two groups of patients with diabetic foot ulcers: one will receive standard of care with timolol while the other will receive standard of care with a gel (hydrogel, as placebo medicine).

Condition or disease Intervention/treatment Phase
Chronic Diabetic Foot Ulcers Diabetic Neuropathic Ulcers Non Healing Wound Drug: Timolol Drug: Non biologically active gel Phase 3

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 Timoptic-XE therapy in conjunction with standard of care (SOC) treatment (Group A: Timoptic-XE + SOC) versus SOC (Group B: SOC + plus a non-biologically active gel, i.e., hydrogel, as placebo medication) in the clinical effectiveness in promoting wound healing and closure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Timolol
Timoptic-XE plus standard of care (SOC)
Drug: Timolol
Topical application of Timolol on non-healing diabetic foot ulcers
Other Name: Timoptic-XE

Placebo Comparator: SOC plus non biologically active gel
SOC plus non biologically active gel (hydrogel as placebo medication)
Drug: Non biologically active gel
Topical application of non biologically active gel (Hydrogel- standard of care) on non-healing diabetic foot ulcers
Other Name: Hydrogel




Primary Outcome Measures :
  1. 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).

  2. Measurement of timolol serum during the treatment phase [ Time Frame: 31 weeks ]
    Primary safety outcome


Secondary Outcome Measures :
  1. The time to wound closure between the two groups [ Time Frame: 31 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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 chronic renal insufficiency requiring dialysis
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282981


Contacts
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Contact: Sara E Dahle, DPM MPH (916) 843-7031 Sara.Dahle@va.gov
Contact: Rivkah R Isseroff, MD (916) 366-5300 rrisseroff@ucdavis.edu

Locations
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United States, California
VA Northern California Health Care System, Mather, CA Recruiting
Sacramento, California, United States, 95655
Contact: Sara E Dahle, DPM MPH    916-843-7031    Sara.Dahle@va.gov   
Principal Investigator: Rivkah R. Isseroff, MD         
Principal Investigator: Sara E. Dahle, DPM MPH         
Sponsors and Collaborators
VA Office of Research and Development
VA Northern California Health Care System
Investigators
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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

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03282981     History of Changes
Other Study ID Numbers: SURG-004-16F
17-08-00792 ( Other Grant/Funding Number: VA Northern California Health Care System )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Agents
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents