TRIAL INTERVENTION for Diabetic Foot Ulcers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Foot UlcersSmith & Nephew Solosite Gel Hydrogel Wound Dressing - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.

Eligible Conditions
  • Diabetic Foot Ulcers

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 60 Days

60 Days
Injury wounds
Injury wounds
60 days
Change in Pain Scores over time (60 days)
Injury wounds
Incidence of wound closures within 60 days
Primary Endpoint
Recurrence

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

TRIAL INTERVENTION
1 of 2
CONTROL THERAPY
1 of 2

Active Control

100 Total Participants · 2 Treatment Groups

Primary Treatment: TRIAL INTERVENTION · No Placebo Group · Phase 2 & 3

TRIAL INTERVENTION
Drug
ActiveComparator Group · 1 Intervention: Lavior Diabetic Wound Gel · Intervention Types: Drug
CONTROL THERAPY
Drug
ActiveComparator Group · 1 Intervention: Smith & Nephew Solosite Gel Hydrogel Wound Dressing · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days

Who is running the clinical trial?

Lavior Pharma Inc.Lead Sponsor
Todd Hassenstein, DPMPrincipal InvestigatorOK Limb Salvage Center

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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