Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04247451 |
| Other study ID # |
BUN 143201941164 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Universitair Ziekenhuis Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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?
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.
