Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
Completed · Not applicable
Conditions studied: Lower Extremity or Diabetic Foot Ulcers, Bacterial Infection
In brief
This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
Key facts
- Study ID
- NCT02294175
- Run by
- North Florida Foundation for Research and Education
- People needed
- 45
- Starts
- 2015-01-01
- Expected to finish
- 2018-03-24
- Last updated by the study team
- 2020-04-07
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans over 21 years of age
- with chronic lower extremity or diabetic foot ulcers (wound duration over 8 weeks)
- who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue)
- wound size 1.5 cm (roughly the size of a quarter) or larger in diameter
You may not qualify if…
- Cognitive impairment that would interfere with patient signing own Informed Consent
- Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) > 3.0, or other significant bleeding risk
- Active immune suppression just prior to or during study (on systemic corticosteroids* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) - *Nasal steroid sprays will not be excluded
- Active systemic antibiotics is an exclusion
- Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) < 0.5 is an exclusion (indicates critical limb ischemia).
- Other possible reasons participants could be removed from this study include: transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study.
Where it is running
- North Florida Regional Medical Center — Gainesville, Florida, United States
- North Florida / South Georgia Veterans Health System — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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