Clinical trial NCT02413086: Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: diabetic foot ulcer
early-stage amputation
external therapy of herbs chitosan
wound surface healing
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 320
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The re-operation rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
measure: Grades of wound healing
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Secondary outcomes:
measure: Healing time
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
measure: The rate of infection
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
measure: Amputation level
timeFrame: At time of surgery.
measure: Trinity amputation and prosthesis experience scale (TAPES)
timeFrame: 7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.
measure: SF-36
timeFrame: 7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Heilongjiang UCM
name: Wang Kuang Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.