Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Ther… (NCT06003530) | Clinical Trial Compass
UnknownPhase 1
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Israel21 participantsStarted 2022-01-06
Plain-language summary
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with Type I or Type 2diabetes and with a neuropathic diabetic foot ulcer for longer than 8 weeks.
* Size of foot ulcer 0.5-13 cm2
* Ulcer graded I by Wager scale
* Ulcer is free of necrotic debris, exhibits no signs of clinical infection
* Ulcer area blood circulation meets one of the following criteria: A. Palpable tibialis anterior and posterior arteries in the affected foot; B. ABI range \>0.7 to \<1.3; C. TcPO2\>30mmHg
Exclusion Criteria:
* Ulcer is of non-diabetic pathophysiology
* The ulcer has decreased in size by \>=30% after the screening visit (week -2 to -4 before treatment)
* Severe hepatic deficiency
* Glycated hemoglobin A1C (HbA1C) level of \>12%
* Postprandial blood sugar \> 350mg/dl
* Require antibiotics to treat the target wound infection within 14 days prior to treatment
* Evidence of current wound infection including pus drainage from wound site
* Severe renal failure (GFR\<30) including subject on renal dialysis
* Pregnant or breastfeeding
* Was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic agents prior to 4 weeks from screening
* Patient receiving anticoagulation therapy except for aspirin
* Underwent wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days prior to screening visit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.