A Phase 2 Randomized Study Comparing Subcutaneous Tumescent Antibiotic Administration With Standard of Care for the Treatment of Chronic Wounds
University of California, Los Angeles
Summary
Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.
Description
Foot ulcers develop in 9.1-26 million people with diabetes annually worldwide. Up to 1% of people in industrialized countries will suffer from a leg ulcer. Numbers of pressure and venous ulcers are rising at rates of 6-7% annually, diabetic ulcers rising at 9%. In the United States, chronic wounds affect 6.5 million patients and over $25 billion dollars are spent annually on chronic wound care. Medicare spending on pressure and arterial ulcers in 2014 was $3696 and $9015 per patient. Diabetic limb complications are more costly than breast cancer. Attempts to treat chronic wounds have included…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female ≥18 years of age. * Must have: 1. One or more full thickness ulcers on the lower extremity, upper extremity (excluding the hands) or trunk with a surface area exceeding 0.5 cm\^2 (50 mm\^2) and less than 30 cm\^2 (6\*5 cm) after debridement (full thickness means extending through the epidermis and dermis but not involving tendon, bone or joint capsule). 2. Presence of a chronic wound (including venous ulcer, arterial ulcer, below knee pressure ulcer, diabetic foot ulcer, ischemic ulcer) that has existed for \>4 weeks at Visit 1. 3. Documentation tha…
Interventions
- DrugCeFAZolin Injectable Solution
One gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline)
Location
- University of California, Los AngelesLos Angeles, California