Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot

NCT06759688 | Completed DMC

• 1 other identifier: AswanUH7
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Carbohydrate Ingestion

Keywords

Diabetic foot wound infections,; Diabetic foot ulcer,; low carbohydrate dietary approaches.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Interventions

Carbohydrates restriction 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.

Also known as: diabetic foot infection with low carbohydrates diet

diabetic foot infection with carbohydrates restriction group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sarah Magdy Abdelmohsen: lead

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)