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临床试验/NCT03816618
NCT03816618已完成早期 1 期

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

Cyberjaya University College of Medical Sciences2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Ulcer size

研究概览

简要总结

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 120 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.

详细描述

The Healing Effects of Honey and Hydrogel Products on the Diabetic Foot. Title 1 TITLE OF RESEARCH PROPOSAL: THE HEALING EFFECTS OF HONEY AND HYDROGEL PRODUCTS ON THE DIABETIC FOOT.

Trial registration 2a Registration by clinical trial. gov, by PRS password available and got approval Number H-04-Q-001 from National Committee of Bio & Med. Ethics(NCBE).

Protocol version 3 Protocol version helps to mitigate potential confusion over which will be started after the ethical approval.

Funding 4 The treatment packs will be prepared by diabetic foot centre, materials: natural drugs, (medihoney gel and purloin gel and fucidine ointment 1%) placebo.

Roles and responsibilities 5a Prof. Dr. Husni Al-Goshae [PHD Neuroscience (UK)], Prof. Dr. Hamdan Noor [PHD Ox Ford University Physiologist], Consultant Dr. Hamad Saleh Alshubrumi [Endocrinologist King Fahad Specialist Hospital, Al-Qassim, KSA].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

CONTROL

Experimental

CONTROL GROUP

干预措施: Fucidin Ointment (Drug)

TREATMENT1

Experimental

TREATMENT GROUP 1

干预措施: Medihoney Gel in A Tube (Drug)

TREATMENT2

Experimental

TREATMENT GROUP 2

干预措施: Hydrogel (Drug)

TREATMENT3

Experimental

TREATMENT GROUP 3

干预措施: Medihoney Gel in A Tube (Drug)

TREATMENT3

Experimental

TREATMENT GROUP 3

干预措施: Hydrogel (Drug)

结局指标

主要结局

Ulcer size

时间窗: FROM 3 WEEKS UP TO 12 WEEKS

ULCER SIZE

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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