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Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Primary Purpose

Diabetic Foot Ulcer, Amputation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TCM
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Traditional Chinese Medicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Well Controlled diabetic state
  • Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
  • Good glycaemic control

Exclusion Criteria:

  • Pregnant women and women at risk of conception
  • Patients taking digitalis glycosides
  • Patients with abnormal liver function tests
  • Patients with plasma creatinine great then 150 umol/l or unstable renal function
  • Poorly controlled Diabetes Mellitus
  • Uncontrolled infection
  • History of adverse reaction to herbal medicine
  • Unstable medical conditions
  • Non-compliance with regime

Sites / Locations

  • Department of Orthopaedics & Traumatology, Prince of Wales hospital
  • Department of Orthopaedics and Traumatology, Kwong Wah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Traditional Chinese Medicine

Placebo

Arm Description

12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.

Placebo was made with starch and colouring materials. Given to patient orally twice a day

Outcomes

Primary Outcome Measures

Number of Participants With Limb Salvage
The number of successful limb rescued (without amputation).

Secondary Outcome Measures

Tumour Necrosis Factor-alpha Levels in Serum
The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.
Time of Ulcer Healing
Time taken for maturation of granulation to enable skin grafting.

Full Information

First Posted
October 26, 2006
Last Updated
July 6, 2010
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00393510
Brief Title
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Official Title
An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation. Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Amputation
Keywords
Diabetic Foot Ulcer, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Chinese Medicine
Arm Type
Active Comparator
Arm Description
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was made with starch and colouring materials. Given to patient orally twice a day
Intervention Type
Drug
Intervention Name(s)
TCM
Intervention Description
The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The formula consisted of 12 herbs, viz: Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The placebo was made with starch and colouring materials.
Primary Outcome Measure Information:
Title
Number of Participants With Limb Salvage
Description
The number of successful limb rescued (without amputation).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Tumour Necrosis Factor-alpha Levels in Serum
Description
The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.
Time Frame
Baseline and 4 week
Title
Time of Ulcer Healing
Description
Time taken for maturation of granulation to enable skin grafting.
Time Frame
24 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Well Controlled diabetic state Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled. Good glycaemic control Exclusion Criteria: Pregnant women and women at risk of conception Patients taking digitalis glycosides Patients with abnormal liver function tests Patients with plasma creatinine great then 150 umol/l or unstable renal function Poorly controlled Diabetes Mellitus Uncontrolled infection History of adverse reaction to herbal medicine Unstable medical conditions Non-compliance with regime
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leung Ping Chung, MD
Organizational Affiliation
Dept. of Orthopaedics & Traumatology, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics & Traumatology, Prince of Wales hospital
City
Hong Kong
Country
China
Facility Name
Department of Orthopaedics and Traumatology, Kwong Wah Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

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