N/A
N=45
Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
Lower Extremity or Diabetic Foot Ulcers · Bacterial Infection
Bottom Line
View on ClinicalTrials.gov: NCT02294175 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating — 9.6561; 9.6880; 11.9611; 9.1547 Natural Log Transformed Bacterial CFU — p=.029
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Larval Debridement Therapy (Device); Bedside Sharp Debridement (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- North Florida Foundation for Research and Education
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating |
9.6561; 9.6880; 11.9611; 9.1547; 11.4864; 10.4479 | .029 sig |
| PRIMARY Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating |
4.5512; 5.4009; 8.9408; 6.2482; 8.9198; 6.8660 | .037 sig |
| PRIMARY Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating |
7.0633; 8.7514; 9.8704; 8.5673; 9.2877; 9.7341 | .012 sig |
| SECONDARY Reviewer Assessment of Visible Wound Improvement |
61.11; 71.88 | .397 |
| SECONDARY Inflammatory Biomarker MMP-9 |
2.8538; 2.8965; 2.7847; 2.7260; 2.9985; 2.6861 | .661 |
| SECONDARY Inflammatory Biomarker IL6 |
3.4889; 3.5748; 4.2287; 4.2233; 4.0069; 4.0096 | .979 |
| SECONDARY Satisfaction With Debridement: Overall Satisfaction With Method, Day 8 |
7.27; 7.13 | .999 |
| SECONDARY Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8 |
2.63; 3.75 | .415 |
| SECONDARY Satisfaction: Difficulty of Use/Care, Day 8 |
1.60; 1.88 | .993 |
| SECONDARY Satisfaction: Wound Pain, Day 8 |
4.14; 3.63 | .990 |
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) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02294175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.