Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer
1 other identifier
interventional
320
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
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
March 23, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedApril 9, 2015
April 1, 2015
3 years
March 23, 2015
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The re-operation rate
Because of diabetic foot ulcer individual was given a re-operation.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Grades of wound healing
As wound healing, wound healing was assessed using 1 to 3 healing grades.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Secondary Outcomes (5)
Healing time
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
The rate of infection
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Amputation level
At time of surgery.
Trinity amputation and prosthesis experience scale (TAPES)
7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.
SF-36
7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.
Study Arms (4)
Early-stage amputation+external herbs chitosan
EXPERIMENTALIndividuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.
Early-stage amputation+traditional gauze
EXPERIMENTALIndividuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.
Amputation+external herbs chitosan
EXPERIMENTALIndividuals with DFU were given amputation and wound was given herbs chitosan after amputation.
Amputation+traditional gauze
EXPERIMENTALIndividuals with DFU were given amputation and wound was given traditional gauze after amputation.
Interventions
Individuals with DFU were given early-stage amputation.
Individuals with DFU were given amputation.
Wound was given external herbs chitosan after amputation.
Wound was given traditional gauze after amputation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 16291063RESULTJiang 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.
PMID: 25573978RESULTYang 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.
PMID: 20578276RESULTCollier 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.
PMID: 21949231RESULTAttinger 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.
PMID: 12644975RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Kuang Yu, Doctor
First Affiliated Hospital of Heilongjiang UCM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Surgery, First Affiliated Hospital of Heilongjiang UCM
Study Record Dates
First Submitted
March 23, 2015
First Posted
April 9, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2018
Last Updated
April 9, 2015
Record last verified: 2015-04