Beta Adrenergic Antagonist for the Healing of Chronic DFU
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetic Neuropathy, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/6/2018 |
| Start Date: | June 14, 2018 |
| End Date: | December 31, 2022 |
| Contact: | Sara E Dahle |
| Email: | Sara.Dahle@va.gov |
Beta Adrenergic Antagonist For The Healing of Chronic Diabetic Foot Ulcers
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).
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).
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
We found this trial at
1
site
Sacramento, California 95655
Principal Investigator: Rivkah R. Isseroff
Phone: 916-216-8194
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