The Healing Effects Of Honey and Hydrogel Products On The Diabetic Foot
Status:
Unknown status
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
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.