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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
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.
The re-operation rate
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.
Grades of wound healing
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.
Healing time
After amputation the time to heal.
Time frame: 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.
Time frame: 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.
Time frame: At time of surgery.
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.
SF-36
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.
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