Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: Early-stage amputation; Procedure: Amputation; Other: External herbs chitosan; Other: Traditional gauze

• Registration Number: NCT02413086
• Lead Sponsor: Heilongjiang University of Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-23
• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-08
• Last Update Submitted: 2015-04-08
• Study First Posted: 2015-04-09
• Last Update Posted: 2015-04-09
• Primary Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Early-stage amputation+traditional gauze	Early-stage amputation	Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.
Amputation+external herbs chitosan	External herbs chitosan	Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.
Early-stage amputation+external herbs chitosan	Early-stage amputation	Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.
Early-stage amputation+external herbs chitosan	External herbs chitosan	Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.
Early-stage amputation+traditional gauze	Traditional gauze	Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.
Amputation+external herbs chitosan	Amputation	Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.
Amputation+traditional gauze	Amputation	Individuals with DFU were given amputation and wound was given traditional gauze after amputation.
Amputation+traditional gauze	Traditional gauze	Individuals with DFU were given amputation and wound was given traditional gauze after amputation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Healing time	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.	After amputation the time to heal.
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.
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.