Carbohydrate IngestionLCNNCT06759688
Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot
An observational study of Carbohydrate Ingestion, run by Sarah Magdy Abdelmohsen at 1 site in Egypt.
Trial summary
A low-carbohydrate diet, when combined with standard wound care and diabetes management, appears to accelerate the healing of infected diabetic foot, improve blood glucose control, reduce systemic inflammation and promoting overall patient recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carbohydrate Ingestion
- What is being tested?
- Carbohydrates restriction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.
Who may be able to join
- Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.
Who cannot join
- Patients with foot gangrene grade 5 The presence of foot ischemia Those who refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
A low-carbohydrate diet, when combined with standard wound care and diabetes management, appears to accelerate the healing of infected diabetic foot, improve blood glucose control, reduce systemic inflammation and promoting overall patient recovery. This approach could be considered a beneficial adjunct therapy in the treatment of diabetic foot infections.
Read the detailed description
The research was a case control study. It conducted prospectively from January 2019 to December 2023 in the surgery department of Aswan university hospital. It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification.
- Conditions
- Carbohydrate Ingestion
- Being tested
- Carbohydrates restriction
- Keywords
- Diabetic foot wound infections,, Diabetic foot ulcer,, low carbohydrate dietary approaches.
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrates restrictionBehavioural
Also called diabetic foot infection with low carbohydrates diet
Patients followed a low carbohydrate dietary approach (LCDs). It means lower than 130 grams carbohydrates per day with special restriction restrictions on:
- Artificial sugars (e.g., sweets, baked goods, pasta, bread).
- Also, rice, butter made from vegetable oils and all types of oils except olive oil.
They were allowed:
- All types of fresh fruits and vegetable.
- Boiled potatoes.
| Study group | Role | What they receive |
|---|---|---|
| diabetic foot infection with carbohydrates restriction group | It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification. Receives: Behavioral: Carbohydrates restriction | |
| diabetic foot infection without carbohydrates restriction | It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the wound size and healing
Wound healing rate (%) = [ (Initial wound size - Wound size after 1 week) / (Initial wound size)] × 100
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbohydrate IngestionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sarah Magdy Abdelmohsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Magdy Abdelmohsen, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759688
- Sponsor's protocol ID
- AswanUH7
- Acronym
- LCN
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot
- ClinicalTrials.gov ID
- NCT06759688
- Acronym / sponsor ID
- LCN / AswanUH7
- Conditions
- Carbohydrate Ingestion
- Keywords
- Diabetic foot wound infections,, Diabetic foot ulcer,, low carbohydrate dietary approaches.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sarah Magdy AbdelmohsenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Jan 2025 (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.
A low-carbohydrate diet, when combined with standard wound care and diabetes management, appears to accelerate the healing of infected diabetic foot, improve blood glucose control, reduce systemic inflammation and promoting overall patient recovery. This approach could be considered a beneficial adjunct therapy in the treatment of diabetic foot infections.
Detailed description
The research was a case control study. It conducted prospectively from January 2019 to December 2023 in the surgery department of Aswan university hospital. It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic foot infection with carbohydrates restriction group | – | Behavioral: Carbohydrates restrictionIt involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification. |
| diabetic foot infection without carbohydrates restriction | – | –It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.
Key inclusion criteria (1 listed)
- Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.
Key exclusion criteria (1 listed)
- Patients with foot gangrene grade 5 The presence of foot ischemia Those who refused to participate
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 |
|---|---|---|
| Carbohydrates restrictionAlso: diabetic foot infection with low carbohydrates dietPatients followed a low carbohydrate dietary approach (LCDs). It means lower than 130 grams carbohydrates per day with special restriction restrictions on: * Artificial sugars (e.g., sweets, baked goods, pasta, bread). * Also, rice, butter made from vegetable oils and all types of oils except olive oil. They were allowed: * All types of fresh fruits and vegetable. * Boiled potatoes. | Behavioural | diabetic foot infection with carbohydrates restriction group |
Primary outcome
Change in the wound size and healing
Time frame: 3-6 months
Wound healing rate (%) = [ (Initial wound size - Wound size after 1 week) / (Initial wound size)] × 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Carbohydrate Ingestion
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Active, not recruiting
Carbohydrate Ingestion Prior to Surgery (CIPS)
Urologic Surgical Procedures, Carbohydrate Loading
Not yet recruiting
Maple Syrup Carbohydrate Dose-Response on 20-km Cycling Time-Trial Performance
Exercise, Endurance Cycling Performance
Recruiting
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise
Exercise Metabolism
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbohydrate Ingestion, run by Sarah Magdy Abdelmohsen at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the wound size and healing (time frame: 3-6 months). 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 7 Jan 2025.