NCT05783700: SCFOOT

Identification of Biomarkers for the Study of the Diabetic Foot and Evolution.

Status unknown Last updated 27 March 2023

What this trial tests

trial testing BIOIMPEDANCEMETRY in Diabetes Mellitus in 300 participants. Status unknown.

Timeline

2 October 2023

Primary endpoint
4 December 2023

7 January 2024

Quick facts

Lead sponsor	Esther Soler
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	2 October 2023
Primary completion	4 December 2023
Estimated completion	7 January 2024

Drugs / interventions tested

• BIOIMPEDANCEMETRY

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Diabetic Foot — all drugs for Diabetic Foot →
• Sarcopenia — all drugs for Sarcopenia →
• Neuropathy, Diabetic — all drugs for Neuropathy, Diabetic →

Sponsor

Esther Soler

Who can join

Adults 18 to 80, any sex, with Diabetes Mellitus or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The European Working Group on Sarcopenia in the Elderly1 defines sarcopenia as a disorder of the progressive and generalized musculoskeletal system \[1\], which is associated with the increase and probability of adverse outcomes including falls, fractures, physical disability, and mortality \[2\]. what is associated with increased and likelihood of adverse outcomes including falls, fractures, disability physical and mortality \[2\]. For a long time, sarcopenia was associated with aging, affecting onlyold people. At present and after several research works related to fragility and theaging, it has been identified that the development of sarcopenia begins earlier in life \[3\], and that there are many contributing causes besides aging \[4\], \[5\]. This new knowledge has implications in the intervention of sarcopenia that prevents or delays its development. Sarcopenia is currently considered a muscle disease (muscle failure), based on adverse changes in the muscles of the musculoskeletal system accumulated throughout life, with loss of muscle strength such as main determinant \[6\], \[7\]. Sarcopenia has been overlooked in clinical practice, apparently due to to the complexity in determining the variables to be measured, how to measure them, and the values or cut-off points can guide diagnosis and treatment, and how best to assess the effects of therapeutic intervention \[8\]. In terms economic, the presence of sarcopenia increases the risk of hospitalization and increases the cost of care during hospital admission \[9\]. Diabetes is the main cause of non-traumatic amputation of the lower limb (MI), being foot ulcers diabetic the cause of 80% of the amputations of people with diabetes\[10\]. A study conducted by the Chongqing University Hospital showed that sarcopenia is independently related to the foot diabetic and that patients with diabetic foot have a worse prognosis if they suffer from sarcopenia. HYPOTHESIS: The surface electromyography (EMGs) signal recording of the foot musculature, will allow extracting biomarkers that allow monitoring and follow-up of sarcopenia in diabetic patients.

MAIN OBJECTIVES: 1- Generate tools based on artificial intelligence (AI) using the database with the biomarkers obtained, in order to analyze the predisposing and triggering risk factors associated with diabetic foot ulcers, according to the IWGDF2. 2- Describe the profile of the diabetic patient in terms of degree of sarcopenia with respect to the population without diabetes in a group of adults. DESIGN: Observational study comparison between cases and controls: a group with the presence of Diabetes Mellitus and another without. SAMPLE: Approximately 16% of diabetic patients will develop an ulcer during their evolution and the Annual incidence is 2-3%, which doubles to 6% in the presence of polyneuropathy. Population of the Department of Health 168,978. Prevalence of diabetes in Spain 7.8%. It is estimated that there are 13,182 in the department people with diabetes. Confidence level 95%, expected frequency of ulcers 6% and confidence limit 9%, it was calculates the sample of 26 patients. 30 patients per group will be recruited. GROUP 1: 30 patients with Diabetes Mellitus. GROUP 2: 30 control patients without Diabetes Mellitus. The period of inclusion of patients is estimated at 5 months. METHOD: the assessment interventions will be carried out in two days. During the first visit, examination to identify risk to the foot: clinical history (PA, comorbidity data, previous injuries to the feet).

feet..), examination of the vascular state, examination of loss of protective sensitivity, perception of pressure, skin inspection, inspection of bone/joint structures, physical limitations and level of knowledge of the foot care. During the second visit: diagnostic tests for sarcopenia (bioimpedance and electromyography), arthropometric measurements, malnutrition, dependence and activity marker tests.

EXPECTED RESULTS: clarify some aspects related to the sarcopenia-diabetic foot binomial, and isolate risk factors for future prevention, by obtaining biomarkers with EMGs in lower limbs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.