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Topical HO/03/03 for Diabetic Foot Ulcers (Truheal Trial)

Phase 2
Waitlist Available
Research Sponsored by HealOr
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 80 years, diagnosed with Diabetes Mellitus Type 1 or Type 2
Ulcer size at randomization: Wagner grade 1, between 2.0 cm2 to 10 cm2, or Wagner grade 2, between 1.0 cm2 to 10 cm2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights

Truheal Trial Summary

This trial is testing the safety and efficacy of a topical treatment for diabetic foot ulcers.

Who is the study for?
Adults aged 18-80 with Type 1 or Type 2 Diabetes and a single, non-healing foot ulcer for at least 4 weeks can join. They must have stable blood sugar levels (HbA1c ≤12%) and be able to follow the study plan. Excluded are those with certain infections, recent steroid or investigational drug use, multiple ulcers, specific foot conditions, substance abuse issues, pregnancy, significant other diseases or surgeries affecting healing.Check my eligibility
What is being tested?
The trial is testing HO/03/03 at a dose of 10µg against a placebo in treating diabetic foot ulcers. Participants will apply the treatment daily for up to 14 weeks. The study aims to see if HO/03/03 is safe and helps heal these ulcers better than a placebo.See study design
What are the potential side effects?
While the potential side effects of HO/03/03 aren't listed here specifically, common topical medication reactions may include skin irritation at the application site such as redness, itching or rash; allergic reactions could also occur.

Truheal Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old and have been diagnosed with Type 1 or Type 2 diabetes.
Select...
My ulcer is between 1.0 cm2 and 10 cm2 in size.
Select...
I can participate in the whole study and follow all the rules.
Select...
I have a non-healing diabetic foot ulcer for over 4 weeks.
Select...
My foot ulcer is not severe and hasn't healed much after treatment.

Truheal Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete ulcer closure
Secondary outcome measures
75% wound closure by or on Study Week 14
Incidence of 100% Closure tested by the Fisher exact 2-tailed test
Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination.
+3 more

Truheal Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HO/03/03 10µgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

HealOrLead Sponsor
3 Previous Clinical Trials
212 Total Patients Enrolled
1 Trials studying Foot Ulcer
22 Patients Enrolled for Foot Ulcer
Cato ResearchIndustry Sponsor
18 Previous Clinical Trials
3,511 Total Patients Enrolled
Clinigene International LtdIndustry Sponsor

Media Library

Foot Ulcer Patient Testimony for trial: Trial Name: NCT00926068 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to register for participation in this experiment?

"This medical trial requires that those who apply have an existing foot ulcer, and be between 18-80 years old. In total, 196 participants must meet the criteria to make it a viable study."

Answered by AI

How many centers are leading the implementation of this experiment?

"At present, St. Vincent Wound Care Center IDI Research in Indianapolis, Indiana, Dr. Ian Gordon in Long Beach, California and North American Centre for Limb Preservation in New Haven, Connecticut are some of the 19 medical centres actively enrolling patients for this investigation."

Answered by AI

Is the population of this clinical trial inclusive to those over thirty years old?

"This trial is open to participants aged 18 and over but not exceeding 80 years."

Answered by AI

Are participants still being admitted to this research project?

"Per clinicaltrials.gov, this medical trial is not presently recruiting for patient participation. It was initially published on February 1st 2010 and most recently edited three years later in April 2013. However, there are currently 390 other trials that have open enrollment at the time of writing."

Answered by AI

Has the FDA sanctioned HO/03/03 10µg?

"Due to the lack of evidence indicating efficacy, our team at Power assigned a score of 2 when judging HO/03/03 10µg's safety profile. This is because it is only in Phase 2 trials and has limited data demonstrating its security."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Center for Curative & Palliative Wound Care Calvary Hospital
Center For Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

i have had foot ulcer at the bottom of my foot. I've tried different medications that haven't worked. It's time to try something new.
PatientReceived 2+ prior treatments
~13 spots leftby Mar 2025