Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot

NCT ID: NCT06759688

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-12-30

Brief 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. 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.

Conditions

Carbohydrate Ingestion

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Carbohydrates restriction

Intervention Type: BEHAVIORAL

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.

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.

No interventions assigned to this group

Interventions

Carbohydrates restriction

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

diabetic foot infection with low carbohydrates diet

Eligibility Criteria

Inclusion Criteria

Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.

Exclusion Criteria

Patients with foot gangrene grade 5 The presence of foot ischemia Those who refused to participate

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sarah Magdy Abdelmohsen

OTHER

Sponsor Role: lead

Responsible Party

Sarah Magdy Abdelmohsen

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Aswan University Hospital

Aswān, , Egypt

Countries

Egypt

Other Identifiers

AswanUH7

Identifier Type: -

Identifier Source: org_study_id