CompletedNot Applicable

Gremlin-1 and Wagner Classification: Potential Biomarker for Amputation in Diabetic Foot Patients

Turkey (Türkiye)85 participantsStarted 2019-12-20

Plain-language summary

The aim of the approach to diabetic foot patients is to heal the wound, mobilize the patient, increase the quality of life, and reduce DA-related amputations as much as possible. For this purpose, early diagnosis and early intervention with multidisciplinary treatment methods are important. There is no marker used to determine the prognosis, predict the progression to amputation, and take precautions for diabetic foot. Based on this need, investigators planned to examine the gremlin-1 level in patients with diabetic foot wounds by grouping them according to the severity of the disease (according to the Wagner classification). There is no previous study examining the relationship between gremlin-1, which has been shown to play a role in inflammation, fibrosis, and angiogenesis, and diabetic foot. In this study, investigators aimed to show the relationship between gremlin-1 in diabetic foot and Wagner classification and its usability as a biomarker in progression to amputation. Being the first study to be conducted on this subject in the literature increases the importance of the project.

Who can participate

Age range

18 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: * 18 years and older * Diagnosed with DM * Who either had diabetic foot ulcers or were at high risk for diabetic foot Exclusion Criteria: * Patients with autoimmune diseases * Malignant conditions * A history of prior amputation * Those on hemodialysis * Pregnant women

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.

What they're measuring

The increase in Wagner stage and the change in Gremlin-1 levels will be monitored and whether Gremlin-1 levels are a prognostic marker for predicting amputation in diabetic patients will be examined.

Timeframe: From enrollment to the end of physical exam and blood analysis at 10 months

Trial details

NCT IDNCT06753604

SponsorSeyma Acik

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-10-20

View on ClinicalTrials.gov More Diabetes Mellitus trials