NCT03816618

Brief 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. 1.What is the effect of Honey and Hydrogel on the foot anatomy and physiology of DF patients?
  2. 2.Could the investigators introduce a new protocol to treat DF using Honey and Hydrogel products?
  3. 3.To provide a new protocol to improve the anatomy and physiology of DF.
  4. 4.To compare the efficacy of combined Hydrogel and Honey products on the diabetic foot ulcer.
  5. 5.To compare the healing time between the patients treated with hydrogel/honey products and the control treatment patients.
  6. 6.To compare Lab parameters improvements between the patients treated with hydrogel/honey products and the control treatment patients.
  7. 7.To compare neurological improvements between the patients treated with hydrogel/honey products and the control treatment patients.
  8. 8.To compare the anatomical improvements between the patients treated with hydrogel/honey products and the control treatment patients.
  9. 9.st group will be treated with topical Medihoney product and empiric antibiotic.
  10. 10.nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic.
  11. 11.rd group will be treated with a combination of Medihoney gel and Hydrogel (purloin) gel and empiric antibiotic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2020

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

January 22, 2019

Last Update Submit

February 16, 2023

Conditions

Diabetic Foot

Keywords

purilon gelmedihoneyfucidine

Outcome Measures

Primary Outcomes (1)

  • Ulcer size

    ULCER SIZE

    FROM 3 WEEKS UP TO 12 WEEKS

Study Arms (4)

CONTROL

EXPERIMENTAL

CONTROL GROUP

Drug: Fucidin Ointment

TREATMENT1

EXPERIMENTAL

TREATMENT GROUP 1

Drug: Medihoney Gel in A Tube

TREATMENT2

EXPERIMENTAL

TREATMENT GROUP 2

Drug: Hydrogel

TREATMENT3

EXPERIMENTAL

TREATMENT GROUP 3

Drug: Medihoney Gel in A TubeDrug: Hydrogel

Interventions

Medihoney Gel in A TubeDRUG

TREATMENT1

Also known as: MEDIHONEY
TREATMENT1TREATMENT3
HydrogelDRUG

PURLOIN GEL

Also known as: PURLOIN
TREATMENT2TREATMENT3
Fucidin OintmentDRUG

FUCIDIN ANTIBIOTIC OINTMENT 10%

Also known as: FUCIDIN OINTMENT 10%
CONTROL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult more or equal 18 years with type 2 DM.
  • Diagnosed with stable DF with any stage of foot ulcer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diabetic Center-KFSH

Buraidah, Al-Qassim, 51411, Saudi Arabia

Location

Diabetes Center, Center Diabetic Foot, King Fahd Specialist Hospital, Ministry Of Health Buraydah; Al Qassim; Saudi Arabia

Buraidah, Elqassim, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Hydrogels

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

GelsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 25, 2019

Study Start

January 1, 2020

Primary Completion

February 1, 2023

Study Completion

February 13, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations

SA(2)