An observational study in Diabetic Foot Ulcer and Type 2 Diabetes, sponsored by Winthrop University Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Winthrop University Hospital · Observational
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Among 381 studies in Diabetic Foot with a site in United States — 66 open to participants now, 85 under way, 3 of them phase 3. Diabetic Foot · United States.
Among the 381 studies in Diabetic Foot with a site in United States, this one is the 42nd largest by enrollment of the 58 observational ones that give a count, is one of 20 that started in 2014, is one of 58 observational ones, and was the 126th registered.
1,078 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →66 of the 381 studies in Diabetic Foot with a site in United States are open now. Recruiting first, the newest first:
Applied Biologics, LLC · Sites in United States
Ages 18+
Biodynamik, Inc · Sites in United States
Ages 22+
Lakewood-Amedex Inc · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
Reprise Biomedical, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
381 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 54 · Phase 3 37 · Phase 4 31
First in 1994; this study’s year is marked. 20 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 100 across 191 observational studies indexed under Diabetic Foot.
Median enrollment 60 across the 322 interventional studies, 138 across the 58 observational. Of the 249 that completed or were terminated, 89 (36%) have results posted.
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253 of 381 have an industry lead sponsor. The 10 most frequent:
Winthrop University Hospital is the lead sponsor of 42 studies on the registry; none are open to participants now.
Winthrop University Hospital has 3 studies filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
34 of the studies in Diabetic Foot with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05369052Phase 3MicuRxSafety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) | 2027-06-30 |
| NCT07852338Phase 3Applied Biologics, LLCa Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers | 2027-09 |
| NCT06420245Legacy Medical ConsultantsClinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | 2026-11 |
| NCT06449638StimLabsModified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs | 2026-11 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
Add all 34 to your calendar (.ics) → With an account.
Among the 381 studies in Diabetic Foot with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.
The goal of this project is to identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds. This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype. The ability to differentiate between healing and non-healing tissue at the onset of wound care will allow for the use of targeted therapies and earlier initiation of aggressive treatments where indicated.
Both male and female patients at Winthrop University Hospital over the age of 18 with Type 2 Diabetes and a Diabetic Foot Ulcer are eligible for enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this group will have tissue specimens collected from their Diabetic Foot Ulcer during Standard of Care debridement.
Other: Specimen Collection
Skin tissue samples will be collected from subjects undergoing routine surgical procedures during which normal skin is removed
Other: Specimen Collection
. In this study, diabetic patients undergoing DFU debridement under the standard of care will be asked for their permission to collect the debrided tissue for use in scientific research.
To identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds
Time frame: Undetermined
Ran from Dec 2014 to primary completion in Dec 2017, 36 months.
Of 65 non-industry observational studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 94. This study's 36 months is above that.
Counting every sponsor, half of 90 studies reached it within 29 months; a quarter within 15 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Winthrop University Hospital