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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-stage amputation+external herbs chitosan | Experimental | Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation. |
|
| Early-stage amputation+traditional gauze | Experimental | Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation. |
|
| Amputation+external herbs chitosan | Experimental | Individuals with DFU were given amputation and wound was given herbs chitosan after amputation. |
|
| Amputation+traditional gauze | Experimental | Individuals with DFU were given amputation and wound was given traditional gauze after amputation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early-stage amputation | Procedure | Individuals with DFU were given early-stage amputation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing time | After amputation the time to heal. | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. |
| The rate of infection | After amputation, there was infection or no infection in the wound. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Kuang Yu, Doctor | Contact | +86 0451-82111401 | wangkuanyu_1964@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Kuang Yu, Doctor | First Affiliated Hospital of Heilongjiang UCM | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16291063 | Result | 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. | |
| 25573978 | Result | 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. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D000671 | Amputation, Surgical |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Amputation | Procedure | Individuals with DFU were given amputation. |
|
| External herbs chitosan | Other | Wound was given external herbs chitosan after amputation. |
|
| Traditional gauze | Other | Wound was given traditional gauze after amputation. |
|
| Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. |
| Amputation level | Amputation level includes metatarsophalangeal joint, metatarsus, foot, ankle, below knee and the lower part of the thigh. | 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 | The medical outcomes study 36-item short form health survey | 7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation. |
| 20578276 | Result | 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. |
| 21949231 | Result | 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. |
| 12644975 | Result | 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |