The Healing Effects Of Honey and Hydrogel Products On The Diabetic Foot

• Status: Unknown status
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The Healing effects of Honey and Hydrogel Products on the Diabetic Foot.

Abstract:

Diabetes mellitus epidemiology is increasing dramatically affecting high numbers of the world's population, one of the highest risk consequences is diabetic foot and which might lead to leg amputation causing a permanent disability for the patient.

Several studies had been conducted on the options available to treat diabetic foot ulcer, Honey products and Hydrogel stands out as an effective topical treatment for the foot ulceration.

This study discusses the effectivity rate of these products and compares it with the classical methods followed to treat DF using topical and systematic antibiotics.

Hence; our research raises the following questions:

1. What is the effect of Honey and Hydrogel on the foot anatomy and physiology of DF patients?

2. Could the investigators introduce a new protocol to treat DF using Honey and Hydrogel products?

Aiming to achieve the following objects:

1. To provide a new protocol to improve the anatomy and physiology of DF.

2. To compare the efficacy of combined Hydrogel and Honey products on the diabetic foot ulcer.

Reaching there the investigators are expecting to:

1. To compare the healing time between the patients treated with hydrogel/honey products and the control treatment patients.

2. To compare Lab parameters improvements between the patients treated with hydrogel/honey products and the control treatment patients.

3. To compare neurological improvements between the patients treated with hydrogel/honey products and the control treatment patients.

4. To compare the anatomical improvements between the patients treated with hydrogel/honey products and the control treatment patients.

In order to provide a clear estimation for the safety and effectivity profile for each treatment method.

Based on that the investigators are conducting using single blinded randomized clinical trial

Suggesting the following Hypothesis: Treatment using topical MediHoney gel and/or Hydrogel together separately in association with empiric antibiotic regimens have a higher success rate comparing with treatment using topical and empiric antibiotic.

A total of 140 DM patients from Outpatients DM type 2 will be included in this study, following up at diabetic foot center Al-Qaseem Saudi Arabia. Patients will be divided into 4 groups:

1. st group will be treated with topical Medihoney product and empiric antibiotic.

2. nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic.

3. rd group will be treated with a combination of Medihoney gel and Hydrogel (purloin) gel and empiric antibiotic.

The 4th group will be treated with a combination of systematic and topical fucidin 1% antibiotic this group will be a controlled group.

Based on the expected results the investigators are estimating that this study will raise the awareness of both health care personnel and the diabetic patients about this condition. It is expected to provide a clear efficacy estimation for each treatment method followed, facilitating the choice of treatment for physicians.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyberjaya University College of Medical Sciences
• Collaborator: Diabetic Center-KFSH
• Treatments: Fusidic Acid

Criteria

Inclusion Criteria:

• Adult more or equal 18 years with type 2 DM.

• Diagnosed with stable DF with any stage of foot ulcer

Exclusion Criteria:

• Patients with unstable severe conditions who requires hospitalization.

• Patients with incomplete data and those who decided to withdraw.

• Read and understood the consent of the research and didn't approve to participate accordingly.

• Patients with open osteomyelitis with discharged us.

• DM patients with ischemic peripheral PAD gangrene.

• Charcoat diabetic foot CDF.