Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot (LCN)

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.

Study Overview

• Status: Completed
• Conditions: Carbohydrate Ingestion
• Intervention / Treatment: Behavioral: Carbohydrates restriction

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: 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.; Other Names: diabetic foot infection with low carbohydrates diet
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the wound size and healing	Wound healing rate (%) = [ (Initial wound size - Wound size after 1 week) / (Initial wound size)] × 100	3-6 months

Collaborators and Investigators

• Sponsor: Sarah Magdy Abdelmohsen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic foot wound infections,; Diabetic foot ulcer,; low carbohydrate dietary approaches.
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: AswanUH7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No