Diabetic Foot UlcerDIM-SUUMNCT04247451
Diabetic Foot Surgery Patients: What is Their Metabolic Profile and Are Nutritional Goals Met
A study testing Metabolic profile and nutritional goals in diabetic foot surgery patients in people with Diabetic Foot Ulcer and Nutrition Disorders, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Nutrition Disorders
- What is being tested?
- Metabolic profile and nutritional goals in diabetic foot surgery patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18years
- under oral or insulin therapy for diabetes mellitus
- patient recruitment at the multidisciplinary at the diabetic wound clinic of the University Hospital Brussel
- scheduled for surgery, with an indication related to the wound(s).
Who cannot join
- Presence of other metabolic diseases (inborn/acquired such as hyperthyroidism)
- Incapacity to undergo research investigations (relative CI to body composition measurement by Bio electrical impedance BIA: cardiac defibrillator)
- Limb- or life threatening disease
- Patient or relatives is/are unable to accurately record dietary intake
Trial locations and contacts
1 site in 1 country.
About this study
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 %.
Read more
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?
Read the detailed description
Diabetes mellitus is an important risk factor for foot ulcers often leading to minor or even major amputations, all with functional impairment.
The pathophysiology of diabetic foot wounds is multifactorial, and a combination of treatment modalities is required to accomplish wound healing. As such, infection control (by means of surgery as well as antibiotics), off-loading and revascularization all contribute to a successful outcome.
Wound healing invariably requires some degree of tissue regeneration, which is an anabolic process that requires ample access to nutrients and energy. In spite of malnutrition being detrimental to wound healing, the nutritional status of the diabetic foot patient is rarely taken into account when devising up a treatment regimen. This is remarkable, as diabetic patients are prone to inadequate energy intake because of three important reasons.
First, they lack insulin, which is considered the main anabolic hormone of the body. Insulin regulates the uptake, storage and conversion of several crucial nutrients, like carbohydrates, fats and proteins, and plays such a pivotal role in energy house holding that diabetes affects almost all cellular processes in the body. Second, diabetic patients are invariably put on a dietary regime in order to maintain strict glycemia control. This requires a patient to schedule meals at very regularly timed intervals, of consistent caloric quantity. In addition, dietary intake has to be adapted to prior or scheduled physical exercise. The primary objective of a diabetes diet being glycemia control may consequently mean that it falls short as an optimal regimen for wound healing.
Third, diabetic foot patients that undergo surgery frequently deviate from their customary diet. Fasting is often mandatory for anesthesia, and is usually prolonged due to neuropathic gastroparesis. Antibiotics may interfere with gastro-intestinal uptake. Hypermetabolic stress due to infection or surgery may temporarily increase energy expenditures.
Low-extremity ulcers are an important health issue, with an extended impact on patients and health. Nutrition as a therapeutic intervention is well established in several domains of medicine, such as the treatment of critically ill patients. A nutritional treatment can alter outcome, when performed in an individualised, patient-tailored setting.
In a randomized prospective way, the investigator's research group proved patient relevant outcome changes when an adequate nutritional therapy was applied: newly diagnosed cancer patients experienced significant less unplanned hospital admissions and saw a decline in the need of dose reduction of their anticancer treatment, as well as a rise in survival. A similar success was seen in a prospective intervention in patients planned for cardiac surgery: a program of close clinical monitoring and interventions by the use of dietary modifications, oral supplements or enteral or parenteral nutrition (or a combination thereof) resulted in a better survival of female patients and a lowered infection rate in male and female CABG and valve surgery patients. There were less episodes of postoperative arrhythmia, and the pneumonia rate went down.
- Conditions
- Diabetic Foot Ulcer, Nutrition Disorders
- Being tested
- Metabolic profile and nutritional goals in diabetic foot surgery patients
- Medical subject headings
- Diabetic Foot, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic profile and nutritional goals in diabetic foot surgery patientsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | 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. Receives: Diagnostic Test: Metabolic profile and nutritional goals in diabetic foot surgery patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %.
Measured: an average of 3 weeks (perioperative period)
Secondary outcomes (2)
Caloric needs (indirect calorimetry; Kcal) in diabetic foot surgery
resting energy expenditure measured by indirect calorimetry before and after surgery
Measured: an average of 3 weeks (perioperative period)
Evaluation of choice for oral nutritional supplements, enteral nutrition and parenteral nutrition (%)
evaluation of nutritional possibilities by health care providers
Measured: an average of 3 weeks (perioperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Why it stopped: low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth De Waele, Universitair Ziekenhuis Brussel
- Investigators
- Elisabeth De Waele, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247451
- Sponsor's protocol ID
- BUN 143201941164
- Acronym
- DIM-SUUM
- Status last verified
- May 2024
- First submitted
- 8 Jan 2020
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Foot Surgery Patients: What is Their Metabolic Profile and Are Nutritional Goals Met
- ClinicalTrials.gov ID
- NCT04247451
- Acronym / sponsor ID
- DIM-SUUM / BUN 143201941164
- Conditions
- Diabetic Foot Ulcer, Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: low inclusion rate
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Diabetes mellitus is an important risk factor for foot ulcers often leading to minor or even major amputations, all with functional impairment.
The pathophysiology of diabetic foot wounds is multifactorial, and a combination of treatment modalities is required to accomplish wound healing. As such, infection control (by means of surgery as well as antibiotics), off-loading and revascularization all contribute to a successful outcome.
Wound healing invariably requires some degree of tissue regeneration, which is an anabolic process that requires ample access to nutrients and energy. In spite of malnutrition being detrimental to wound healing, the nutritional status of the diabetic foot patient is rarely taken into account when devising up a treatment regimen. This is remarkable, as diabetic patients are prone to inadequate energy intake because of three important reasons.
First, they lack insulin, which is considered the main anabolic hormone of the body. Insulin regulates the uptake, storage and conversion of several crucial nutrients, like carbohydrates, fats and proteins, and plays such a pivotal role in energy house holding that diabetes affects almost all cellular processes in the body. Second, diabetic patients are invariably put on a dietary regime in order to maintain strict glycemia control. This requires a patient to schedule meals at very regularly timed intervals, of consistent caloric quantity. In addition, dietary intake has to be adapted to prior or scheduled physical exercise. The primary objective of a diabetes diet being glycemia control may consequently mean that it falls short as an optimal regimen for wound healing.
Third, diabetic foot patients that undergo surgery frequently deviate from their customary diet. Fasting is often mandatory for anesthesia, and is usually prolonged due to neuropathic gastroparesis. Antibiotics may interfere with gastro-intestinal uptake. Hypermetabolic stress due to infection or surgery may temporarily increase energy expenditures.
Low-extremity ulcers are an important health issue, with an extended impact on patients and health. Nutrition as a therapeutic intervention is well established in several domains of medicine, such as the treatment of critically ill patients. A nutritional treatment can alter outcome, when performed in an individualised, patient-tailored setting.
In a randomized prospective way, the investigator's research group proved patient relevant outcome changes when an adequate nutritional therapy was applied: newly diagnosed cancer patients experienced significant less unplanned hospital admissions and saw a decline in the need of dose reduction of their anticancer treatment, as well as a rise in survival. A similar success was seen in a prospective intervention in patients planned for cardiac surgery: a program of close clinical monitoring and interventions by the use of dietary modifications, oral supplements or enteral or parenteral nutrition (or a combination thereof) resulted in a better survival of female patients and a lowered infection rate in male and female CABG and valve surgery patients. There were less episodes of postoperative arrhythmia, and the pneumonia rate went down.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Diagnostic Test: Metabolic profile and nutritional goals in diabetic foot surgery patientsNutritional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18years
- under oral or insulin therapy for diabetes mellitus
- patient recruitment at the multidisciplinary at the diabetic wound clinic of the University Hospital Brussel
- scheduled for surgery, with an indication related to the wound(s).
Key exclusion criteria (4 listed)
- Presence of other metabolic diseases (inborn/acquired such as hyperthyroidism)
- Incapacity to undergo research investigations (relative CI to body composition measurement by Bio electrical impedance BIA: cardiac defibrillator)
- Limb- or life threatening disease
- Patient or relatives is/are unable to accurately record dietary intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic profile and nutritional goals in diabetic foot surgery patientsNutritional 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. | Diagnostic test | Interventional group |
Primary outcome
Efficiency of nutritional therapy: Dietary intake (food diary; in Kcal) compared to caloric need (indirect calorimetry; Kcal)
Time frame: an average of 3 weeks (perioperative period)
Actual daily caloric and protein intake compared to the calculated need. These values will each be presented as relative %.
2 secondary outcomes
Caloric needs (indirect calorimetry; Kcal) in diabetic foot surgery
Time frame: an average of 3 weeks (perioperative period)
Evaluation of choice for oral nutritional supplements, enteral nutrition and parenteral nutrition (%)
Time frame: an average of 3 weeks (perioperative period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth De Waele, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic profile and nutritional goals in diabetic foot surgery patients in people with Diabetic Foot Ulcer and Nutrition Disorders, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 inclusion and 4 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: paused, as of the sponsor's last update on 9 May 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 Belgium. 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?
Results are not available in the source record.
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?
Efficiency of nutritional therapy: Dietary intake (food diary; in Kcal) compared to caloric need (indirect calorimetry; Kcal) (time frame: an average of 3 weeks (perioperative period)). 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 9 May 2024.