Status:
COMPLETED
Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
Lead Sponsor:
North Florida Foundation for Research and Education
Collaborating Sponsors:
North Florida/South Georgia Veterans Health System
Biomonde
Conditions:
Lower Extremity or Diabetic Foot Ulcers
Bacterial Infection
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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)...
Detailed Description
Drug resistant organisms and bacterial biofilm pose an increasing threat to the health of millions of individuals world-wide. These organisms are being identified with an alarming prevalence among per...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02294175
Start Date
January 1 2015
End Date
March 24 2018
Last Update
April 7 2020
Active Locations (2)
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1
North Florida Regional Medical Center
Gainesville, Florida, United States, 32605
2
North Florida / South Georgia Veterans Health System
Gainesville, Florida, United States, 32608