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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

Must not have

Have a documented medical history of HIV, HBV or HCV

Plantar Neuropathic DFU is located on an active Charcot foot

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 weeks inclusive

Awards & highlights

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old and have been diagnosed with Type 1 or Type 2 diabetes.

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My ulcer is between 1.0 cm2 and 10 cm2 in size.

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I can participate in the whole study and follow all the rules.

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My foot ulcer is not severe and hasn't healed much after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV, HBV, or HCV.

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My foot ulcer is on a foot with active Charcot disease.

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I have a serious heart, lung, stomach, hormone (except diabetes), metabolism, brain, liver, kidney disease, or I'm on dialysis.

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I have signs of infection in a wound, such as fever or redness.

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I am unable to leave my bed or visit the clinic.

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I have more than one non-healing foot ulcer due to diabetes.

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I have a hind foot ulcer or a condition that stops me from using special footwear.

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I am taking more than 10 mg/day of Prednisone or its equivalent.

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I haven't had any serious illnesses in the last 4 weeks.

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I have taken antibiotics during the screening period.

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I had surgery to improve blood flow in my leg within the last 6 months or might need one.

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I cannot stop using my current wound healing treatments after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 weeks inclusive

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 weeks inclusive

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 weeks inclusive for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete ulcer closure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HO/03/03 10µgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cato ResearchIndustry Sponsor

18 Previous Clinical Trials

3,511 Total Patients Enrolled

HealOrLead Sponsor

3 Previous Clinical Trials

212 Total Patients Enrolled

1 Trials studying Foot Ulcer

22 Patients Enrolled for Foot Ulcer

Clinigene International LtdIndustry Sponsor

Media Library

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

~13 spots leftby Sep 2025

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