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Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early-stage amputation
Amputation
External herbs chitosan
Traditional gauze
Sponsored by
Heilongjiang University of Chinese Medicine
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, early-stage amputation, external therapy of herbs chitosan, wound surface healing

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. According to Chinese herbs medicine standard for the diagnosis and treatment of diabetic foot, the individual diagnosed as diabetic foot with acromelic gangrene.
  2. The individual aged between 18 and 70 years.
  3. All wounds corresponded to Wagner classification grade 4 or 5.
  4. By appropriate treatment, skin temperature of limb with ulcer became warmer and it proved that the blood circulation recovery could be happening.
  5. There were no obvious bruises or chromatosis in the necrosis skin.
  6. Persistent limb pain affected the sleep of the individuals.
  7. The individual voluntarily signed the informed consent form.

Exclusion Criteria:

  1. Acromelic gangrene caused by other reasons.
  2. The individuals with server cardiovascular and cerebrovascular diseases or hepatic and kidney diseases do not adhere to surgery.
  3. The individuals with the history of amputation.
  4. The individuals with systemic inflammatory response syndrome, Bacteremia, Pyemia or shock.
  5. Vascular ultrasound shows artery is completely blocked.
  6. The individuals do not adhere to the treatment or are with other treatments.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Early-stage amputation+external herbs chitosan

    Early-stage amputation+traditional gauze

    Amputation+external herbs chitosan

    Amputation+traditional gauze

    Arm Description

    Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.

    Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.

    Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.

    Individuals with DFU were given amputation and wound was given traditional gauze after amputation.

    Outcomes

    Primary Outcome Measures

    The re-operation rate
    Because of diabetic foot ulcer individual was given a re-operation.
    Grades of wound healing
    As wound healing, wound healing was assessed using 1 to 3 healing grades.

    Secondary Outcome Measures

    Healing time
    After amputation the time to heal.
    The rate of infection
    After amputation, there was infection or no infection in the wound.
    Amputation level
    Amputation level includes metatarsophalangeal joint, metatarsus, foot, ankle, below knee and the lower part of the thigh.
    Trinity amputation and prosthesis experience scale (TAPES)
    SF-36
    The medical outcomes study 36-item short form health survey

    Full Information

    First Posted
    March 23, 2015
    Last Updated
    April 8, 2015
    Sponsor
    Heilongjiang University of Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02413086
    Brief Title
    Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Heilongjiang University of Chinese Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors leading to limb amputation, it was reported that the amputation rate is 15 times of the non-diabetic patients. Common surgical amputation is not only about high plane amputation but also bring a tremendous mental stress to patients which may affect the quality of life seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia , and septic shock which could be the main cause of death before amputation. It become an important topic that how to control the infection, reduce the amputation plane, save the function as possibility, and improve the life quality of the patients as well. This study is based on years of clinical experience of and brings out "early-stage amputation" concept firstly in China with a systematic exposition, experimental research and clinical research. Early-stage amputation refers to cut in the normal tissue from the inflammatory tissue at the junction line of limbs, in order to achieve more retained stump, block endotoxin absorption and improve the quality of life of patients. External therapy of herbs chitosan can promote granulation tissue regeneration and control of local infection, it solved the problem of difficult wound healing and it is a reliable guarantee of early-stage amputation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Ulcer
    Keywords
    diabetic foot ulcer, early-stage amputation, external therapy of herbs chitosan, wound surface healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    320 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early-stage amputation+external herbs chitosan
    Arm Type
    Experimental
    Arm Description
    Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.
    Arm Title
    Early-stage amputation+traditional gauze
    Arm Type
    Experimental
    Arm Description
    Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.
    Arm Title
    Amputation+external herbs chitosan
    Arm Type
    Experimental
    Arm Description
    Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.
    Arm Title
    Amputation+traditional gauze
    Arm Type
    Experimental
    Arm Description
    Individuals with DFU were given amputation and wound was given traditional gauze after amputation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Early-stage amputation
    Intervention Description
    Individuals with DFU were given early-stage amputation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Amputation
    Intervention Description
    Individuals with DFU were given amputation.
    Intervention Type
    Other
    Intervention Name(s)
    External herbs chitosan
    Intervention Description
    Wound was given external herbs chitosan after amputation.
    Intervention Type
    Other
    Intervention Name(s)
    Traditional gauze
    Intervention Description
    Wound was given traditional gauze after amputation.
    Primary Outcome Measure Information:
    Title
    The re-operation rate
    Description
    Because of diabetic foot ulcer individual was given a re-operation.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
    Title
    Grades of wound healing
    Description
    As wound healing, wound healing was assessed using 1 to 3 healing grades.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
    Secondary Outcome Measure Information:
    Title
    Healing time
    Description
    After amputation the time to heal.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
    Title
    The rate of infection
    Description
    After amputation, there was infection or no infection in the wound.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
    Title
    Amputation level
    Description
    Amputation level includes metatarsophalangeal joint, metatarsus, foot, ankle, below knee and the lower part of the thigh.
    Time Frame
    At time of surgery.
    Title
    Trinity amputation and prosthesis experience scale (TAPES)
    Time Frame
    7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.
    Title
    SF-36
    Description
    The medical outcomes study 36-item short form health survey
    Time Frame
    7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: According to Chinese herbs medicine standard for the diagnosis and treatment of diabetic foot, the individual diagnosed as diabetic foot with acromelic gangrene. The individual aged between 18 and 70 years. All wounds corresponded to Wagner classification grade 4 or 5. By appropriate treatment, skin temperature of limb with ulcer became warmer and it proved that the blood circulation recovery could be happening. There were no obvious bruises or chromatosis in the necrosis skin. Persistent limb pain affected the sleep of the individuals. The individual voluntarily signed the informed consent form. Exclusion Criteria: Acromelic gangrene caused by other reasons. The individuals with server cardiovascular and cerebrovascular diseases or hepatic and kidney diseases do not adhere to surgery. The individuals with the history of amputation. The individuals with systemic inflammatory response syndrome, Bacteremia, Pyemia or shock. Vascular ultrasound shows artery is completely blocked. The individuals do not adhere to the treatment or are with other treatments.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wang Kuang Yu, Doctor
    Phone
    +86 0451-82111401
    Email
    wangkuanyu_1964@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang Kuang Yu, Doctor
    Organizational Affiliation
    First Affiliated Hospital of Heilongjiang UCM
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16291063
    Citation
    Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
    Results Reference
    result
    PubMed Identifier
    25573978
    Citation
    Jiang Y, Ran X, Jia L, Yang C, Wang P, Ma J, Chen B, Yu Y, Feng B, Chen L, Yin H, Cheng Z, Yan Z, Yang Y, Liu F, Xu Z. Epidemiology of type 2 diabetic foot problems and predictive factors for amputation in China. Int J Low Extrem Wounds. 2015 Mar;14(1):19-27. doi: 10.1177/1534734614564867. Epub 2015 Jan 8.
    Results Reference
    result
    PubMed Identifier
    20578276
    Citation
    Yang SH, Dou KF, Song WJ. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Jun 24;362(25):2425-6; author reply 2426. No abstract available.
    Results Reference
    result
    PubMed Identifier
    21949231
    Citation
    Collier A, Dowie A, Ghosh S, Brown PC, Malik I, Boom S. Diabetic foot ulcer: amputation on request? Diabetes Care. 2011 Oct;34(10):e159. doi: 10.2337/dc10-2183. No abstract available.
    Results Reference
    result
    PubMed Identifier
    12644975
    Citation
    Attinger C, Venturi M, Kim K, Ribiero C. Maximizing length and optimizing biomechanics in foot amputations by avoiding cookbook recipes for amputation. Semin Vasc Surg. 2003 Mar;16(1):44-66. doi: 10.1053/svas.2003.50006. No abstract available.
    Results Reference
    result

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    Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer

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