Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer
NCT ID: NCT02413086
Last Updated: 2015-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
320 participants
INTERVENTIONAL
2015-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Early-stage amputation+external herbs chitosan
Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.
Early-stage amputation
Individuals with DFU were given early-stage amputation.
External herbs chitosan
Wound was given external herbs chitosan after amputation.
Early-stage amputation+traditional gauze
Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.
Early-stage amputation
Individuals with DFU were given early-stage amputation.
Traditional gauze
Wound was given traditional gauze after amputation.
Amputation+external herbs chitosan
Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.
Amputation
Individuals with DFU were given amputation.
External herbs chitosan
Wound was given external herbs chitosan after amputation.
Amputation+traditional gauze
Individuals with DFU were given amputation and wound was given traditional gauze after amputation.
Amputation
Individuals with DFU were given amputation.
Traditional gauze
Wound was given traditional gauze after amputation.
Interventions
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Early-stage amputation
Individuals with DFU were given early-stage amputation.
Amputation
Individuals with DFU were given amputation.
External herbs chitosan
Wound was given external herbs chitosan after amputation.
Traditional gauze
Wound was given traditional gauze after amputation.
Eligibility Criteria
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Inclusion Criteria
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
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.
17 Years
70 Years
ALL
No
Sponsors
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Heilongjiang University of Chinese Medicine
OTHER
Responsible Party
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Wang Kuanyu
Director of Department of Surgery, First Affiliated Hospital of Heilongjiang UCM
Principal Investigators
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Wang Kuang Yu, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Heilongjiang UCM
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ESA-EHC-DFU-2014
Identifier Type: -
Identifier Source: org_study_id
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