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Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm

NCT02294175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-04-07

Study results available
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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.

Conditions

Interventions

DEVICE

Larval Debridement Therapy

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

PROCEDURE

Bedside Sharp Debridement

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

Sponsors & Collaborators

  • North Florida/South Georgia Veterans Health System

    collaborator OTHER

  • Biomonde

    collaborator INDUSTRY

  • North Florida Foundation for Research and Education

    lead OTHER

Principal Investigators

  • Linda J Cowan, PhD · North Florida/South Georgia Veterans Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2018-03-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02294175 on ClinicalTrials.gov