CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Larval Debridement Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02294175
NCT02294175N/ACompleted

RCT: Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm From Chronic Lower Extremity or Diabetic Foot Ulcers

North Florida Foundation for Research and Education·interventional·Posted Nov 19, 2014·Updated Apr 7, 2020

In Brief

A clinical study evaluating Larval Debridement Therapy and Bedside Sharp Debridement for Lower Extremity or Diabetic Foot Ulcers and Bacterial Infection. Completed, enrolled 45 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 19, 2014
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2017
Study CompletionMar 24, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.6 years ago

Interventions

Larval Debridement Therapydevice

small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

Bedside Sharp Debridementprocedure

The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound