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Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer

NCT03574935 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-07-02

No results posted yet for this study

Summary

This project is based on investigator team's ten year experience on diabetic ulcer and goes on further developing basic research and concluding clinical experience. The investigator team has recently developed "Remove stasis to generate granulation tissue" into "Remove slough to generate granulation tissue". Investigators have applied the principle of "Remove stasis" in the medium and later stage of treatment to make "Remove slough-Eliminate stasis-Generate granulation tissue" become the basic principle of three-stage sequential treatment. Investigators will further conclude Chinese medicine therapy in the stage of "Qing-Hua-Bu" and evaluate safety, applicability and availability of it. Therefore, the research can help improve clinical diagnosis and treatment technique and transfer the study result of Chinese medicine experience on diabetic ulcer.

Conditions

  • Diabetic Foot
  • Ulcer, Skin

Interventions

DRUG

External Chinese medicine

External Chinese medicine: For patients in the treatment group, they will accept one of three specific External Chinese medicine according to their lesions and corresponding syndromes: 1. Chinese herb of "Clear heat-Remove dampness-Detoxicate" for patients belong to heat syndrome; 2. Chinese herb of "Activating blood-Removing stasis" for patients belong to stasis syndrome; 3. Chinese herb of "Supplement deficiency-Generate muscles" for patients belong to deficiency syndrome.

DRUG

External Western medicine

For patients in the control group, they will accept one of three specific external Western medicine according to their lesions: 1.Ethacridine Lactate Solution(lesions with much effusion)； 2.1% Sulfadiazine Silver Cream（lesions with infection）； 3.rb-bFGF(lesions with no slough and look clear).

Sponsors & Collaborators

  • Shanghai Yueyang Integrated Medicine Hospital

    lead OTHER

Principal Investigators

  • Jia Zhou · Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-09-30
Completion
2019-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574935 on ClinicalTrials.gov