Diabetic Foot Ulcer
Conditions
Keywords
diabetic foot ulcer, early-stage amputation, external therapy of herbs chitosan, wound surface healing
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.
Interventions
PROCEDUREEarly-stage amputation
Individuals with DFU were given early-stage amputation.
PROCEDUREAmputation
Individuals with DFU were given amputation.
OTHERExternal herbs chitosan
Wound was given external herbs chitosan after amputation.
OTHERTraditional gauze
Wound was given traditional gauze after amputation.
Sponsors
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The re-operation rate | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. | Because of diabetic foot ulcer individual was given a re-operation. |
| Grades of wound healing | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. | As wound healing, wound healing was assessed using 1 to 3 healing grades. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 | 7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation. | The medical outcomes study 36-item short form health survey |
| Amputation level | At time of surgery. | Amputation level includes metatarsophalangeal joint, metatarsus, foot, ankle, below knee and the lower part of the thigh. |
| The rate of infection | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. | After amputation, there was infection or no infection in the wound. |
| Healing time | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. | After amputation the time to heal. |
| 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. | — |
Contacts
Primary ContactWang Kuang Yu, Doctor
Outcome results
None listed