An observational study in Diabetic Foot Ulcers, sponsored by Winthrop University Hospital. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. 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 55th largest by enrollment of the 58 observational ones that give a count, is one of 20 that started in 2013, is one of 58 observational ones, and was the 102nd 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: 21 Years and older · all sexes · no healthy volunteers.
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 2013.
By drug class, each counting the studies that test any of its medicines:
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 |
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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.
The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to diabetic foot ulcer healing and for the purpose of developing the clinical decision support alert system.
After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months.
Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.
Male or female patients at Winthrop University Hospital diagnosed with a Diabetic Foot Ulcer.
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.
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.
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.
Questionnaire relevant to wound healing
* How do different types of bacterial infections affect DFU healing? * Does informing the patient and their families about wound characteristics improve DFU healing? * Which treatment modalities are the most optimal for managing patients with complicated DFUs (e.g. ischemic, infected)? * How does providing the patient with an individualized data summary and photos of their wound affect wound healing?
Time frame: up to 6 months
Develop new parameters for clinical decision support based on data collected in this study.
Time frame: up to 6 months
The record gives a start of Apr 2013, a primary completion of Apr 2018 and a completion of Apr 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Winthrop University Hospital