Standard Care for Diabetic Foot Infection

Phase-Based Progress Estimates
University of Miami, Miami, FLDiabetic Foot Infection+2 MoreStandard Care - Other
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new treatment for diabetic foot ulcers, comparing it to standard care. The new treatment is a patch made from human placental umbilical cord tissue, applied every 4 weeks. The trial will measure how many ulcers are completely healed within 26 weeks.

Eligible Conditions
  • Non Healing Wounds
  • Diabetic Foot Infection
  • Non Healing Diabetic Foot Ulcer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: by Week 50

Week 50
Patient-reported mobility
by Week 50
Complete wound healing
Limb preservation
Wound durability

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

220 Total Participants · 1 Treatment Group

Primary Treatment: Standard Care · No Placebo Group · Phase 3

TTAX01Experimental Group · 2 Interventions: Standard Care, TTAX01 · Intervention Types: Other, Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: by week 50

Who is running the clinical trial?

Tissue Tech Inc.Lead Sponsor
14 Previous Clinical Trials
682 Total Patients Enrolled
Herbert Slade, MDStudy ChairChief Medical Officer
1 Previous Clinical Trials
220 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The ulcer you have is on the bottom, between the toes, heel, or sides of your foot.

Frequently Asked Questions

Could you give me a breakdown of the patients who have signed up for this clinical trial?

"The sponsor, Tissue Tech Inc., needs to recruit 220 eligible patients from different locations in order to run the study. Some of these participating centres include Paley Orthopedic & Spine Institute and UCLA Olive View." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Standard Care?

"Standard Care received a score of 3 on Power's safety scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.