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Diabetes MellitusNCT06753604

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

An observational study of Diabetes Mellitus and Diabetic Foot Disease, run by Seyma Acik at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
85 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Dec 2019to 27 Feb 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diabetic foot who apply to the endocrinology outpatient clinic and are evaluated by the diabetic foot council.

Who may be able to join

  • 18 years and older
  • Diagnosed with DM
  • Who either had diabetic foot ulcers or were at high risk for diabetic foot

Who cannot join

  • Patients with autoimmune diseases
  • Malignant conditions
  • A history of prior amputation
  • Those on hemodialysis
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ege University

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Relationship Between Gremlin-1 Levels and Wagner Classification inDiabetic Foot Patients and Evaluation of Its Usability as a Biomarker in the Progress toAmputation

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.

Read the detailed description

Diabetic foot (DA), a microvascular complication of diabetes mellitus (DM), is a significant cause of morbidity and mortality. While the prevalence of diabetic foot is reported to be between 4 and 10%, the lifetime risk of developing DA in a person diagnosed with diabetes is as high as 25%. Diabetic foot wounds lead to deterioration of the patient's quality of life, loss of work power, psychosocial trauma, and increased health care costs. These are the most common causes of hospitalization and longest hospital stay in diabetic patients. 50-70% of non-traumatic foot amputations are performed in diabetic patients. It is known that different mechanisms such as neuropathic degeneration (autonomic, motor, sensory), vasculopathy (micro and macroangiopathy), poorly controlled infection, and poor wound healing due to impaired collagen production are together in the etiopathogenesis of DA. In addition, opsonization and phagocytosis processes are reduced in diabetic patients. The decrease in chemotaxis and proliferation of cells responsible for inflammation and especially macrophages that stimulate wound healing by secreting various growth factors is one of the most important factors that delay wound healing. The characteristic feature in a diabetic foot case is a prolonged acute phase reaction. The first step in managing diabetic foot wounds is the evaluation, grading, and classification of the ulcer. There is no commonly agreed classification to be used in diabetic feet. Wagner-Meggit classification, San Antonio classification, University of Texas classification, PEDIS staging are a few of them. Each diabetic foot council uses its own appropriate classification. DA classification is an important guide in deciding on the treatment method and proceeding to amputation. Acute phase reactants such as C-reactive protein (CRP), white blood cell (WBC), neutrophil count, and sedimentation rate (ESR) are widely used as laboratory markers of progressing to amputation in DA, but these are insufficient to reflect the severity of DA disease. In addition, since no systemic effects can be seen in non-infected DA ulcers, an increase in acute-phase reactants may not be detected. For these reasons, new marker studies are needed to predict the prognosis of diabetic feet and determine the severity of the disease. Based on this need, investigators planned to examine the gremlin-1 level in DA foot cases in this study. Gremlin-1 is an extracellular antagonist of bone morphogenetic proteins (BMP) and works by directly neutralizing its ligands and inhibiting BMP signaling. BMP, a subgroup of TGF-B (transforming growth factor), an important pro-fibrinogenic cytokine, is known to have an anti-fibrinogenic role in various organs. BMP and its antagonist gremlin are developmental genes that regulate morphogenesis, and their role in embryogenesis has been clearly demonstrated in limb development, neural crest differentiation, and metanephric kidney organogenesis. Gremlin is silenced in adult tissues, but its induction in injured tissues has been described. Gremlin-1 expression has been shown to increase in pulmonary fibrosis, diabetic nephropathy, fibrotic liver diseases, and various malignancies. These findings indicate that Gremlin-1 plays a role in organ fibrosis. In addition, gremlin-1 plays a role in angiogenesis by binding to vascular endothelial factor receptor-2 (VEGFR-2) in endothelial cells. It is obvious that there is increased inflammation and accompanying fibrosis and angiogenesis during the healing process of DA wounds. Therefore, investigators aimed to examine the relationship between gremlin-1 levels and Wagner classification in DA cases and to test its usability as a biomarker in the progression to amputation.

Keywords
diabetic foot, gremlin-1, amputation
Medical subject headings
Diabetes Mellitus, Diabetic Foot, Diabetic Neuropathies, Peripheral Arterial Disease, Polyposis Syndrome, Hereditary Mixed, 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06753604
Study groupRoleWhat they receive
patients with diabetic footPatients were divided into groups according to the stage of diabetic foot ulcer. Patients were staged according to the Wagner classification.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    The Gremlin-1 levels of the patients included in the study will be evaluated between the groups according to their Wagner stage, and the statistical correlation between Wagner stage and Gremlin-1 will be investigated.

    Gremlin-1 levels will also be compared between amputee and non-amputee patients. It will be evaluated whether Gremlin-1 levels can be used as a prognostic marker in predicting amputation in diabetic patients.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start20 Dec 2019
  3. Primary completion20 Oct 2020
  4. Study completion27 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
85 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753604
Sponsor's protocol ID
TTU-2020-21555
Status last verified
Dec 2024
First submitted
18 Dec 2024
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Diabetic Foot Disease, run by Seyma Acik at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From enrollment to the end of physical exam and blood analysis at 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.

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