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Diabetic Foot Surgery Patients: What is Their Metabolic Profile and Are Nutritional Goals Met

NCT04247451 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-09

No results posted yet for this study

Summary

Prospective interventional follow-up of diabetic foot surgery patients, their metabolic/nutritional profile, and the nutritional adequacy in the perioperative setting.

Primary objective: to establish the preoperative metabolic profile of diabetic patients scheduled for foot surgery and determine the postoperative nutritional status. The daily values of caloric intake compared to caloric need and protein intake compared to protein need will be evaluated as primary endpoint. \[Actual daily caloric and protein intake is compared to the calculated need.\] These values will each be presented as relative %.

Wound healing is an anabolic process that requires ample access to nutrients. Insulin is considered the main anabolic hormone of the body, and regulates the metabolism of carbohydrates, fats and proteins. Diabetic patients lack this very hormone, and in addition are required to follow a strict dietary regime that further limits caloric and protein intake. Very little research had been done to evaluate the role of malnutrition in delayed wound healing.

Overall: What is the metabolic/nutritional profile of a diabetes patient with foot wounds undergoing surgery? Is the intake of proteins and caloric adequate in the perioperative setting and are nutritional goals met? Is there a possibility for iatrogenic malnutrition? What kind of nutrition would possibly be useful to optimize intake?

Conditions

  • Diabetic Foot Ulcer
  • Nutrition Disorders

Interventions

DIAGNOSTIC_TEST

Metabolic profile and nutritional goals in diabetic foot surgery patients

Nutritional intake: these data will be evaluated daily during preoperative hospitalization, at home, and during the actual hospitalization, from surgical intervention to discharge. Before the follow-up consultation, patients will keep a food diary. The dieticians will calculate intake and need. Metabolic data: body composition using Bio electrical Impedance Analysis BIA (Nutrilab Akern) and Resting Energy Expenditure REE using indirect calorimetry (Cosmed Q NRG) will be analysed in three timepoints: preoperative, postoperative and at follow-up consultation. This measurements take maximum ten minutes and do not cause discomfort to the participants.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Elisabeth De Waele, MD, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247451 on ClinicalTrials.gov