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

NCT06753604 | Completed

• 1 other identifier: TTU-2020-21555
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Diabetic Foot Disease; Diabetic Foot Ulcer; Diabetic Neuropathy; Peripheral Arterial Disease

Keywords

diabetic foot; gremlin-1; amputation

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

patients with diabetic foot

Patients were divided into groups according to the stage of diabetic foot ulcer. Patients were staged according to the Wagner classification.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seyma Acik: lead
• Ege University: collaborator

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Diabetic Neuropathies; Peripheral Arterial Disease; Polyposis Syndrome, Hereditary Mixed, 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator Medical Doctor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: December 20, 2019
• Primary Completion: October 20, 2020
• Study Completion: February 27, 2021
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years after the publication of results

Locations

TU (1)