NCT04247451|Suspended
Study Stopped
low inclusion rate
Diabetic Foot Surgery Patients: What is Their Metabolic Profile and Are Nutritional Goals Met
DIM-SUUM
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Sponsor study identifier
interventional
20
1 country
1
Study Start
January 1, 2020
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2020
Actual (reported)January 8, 2020
Actual (reported)January 30, 2020
Actual (reported)December 31, 2023
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Efficiency of nutritional therapy: Dietary intake (food diary; in Kcal) compared to caloric need (indirect calorimetry; Kcal)
Actual daily caloric and protein intake compared to the calculated need. These values will each be presented as relative %.
an average of 3 weeks (perioperative period)
Caloric needs (indirect calorimetry; Kcal) in diabetic foot surgery
an average of 3 weeks (perioperative period)
Evaluation of choice for oral nutritional supplements, enteral nutrition and parenteral nutrition (%)
an average of 3 weeks (perioperative period)
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 BIA (Nutrilab Akern) and REE using indirect calorimetry (Cosmed Q NRG) will be analyzed in three timepoints: preoperative, postoperative and at follow-up consultation. This measurements take maximum ten minutes and do not cause discomfort to the participants.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UZ Brussel
Brussels, Belgium
Elisabeth De Waele, MD, PhD
Universitair Ziekenhuis Brussel
20 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2020
First Posted
January 30, 2020
Study Start
January 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2023
Actual (reported)Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 9, 2024
Record last verified: 2024-05
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