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

Heilongjiang University of Chinese Medicine

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Other: Traditional gauze; Procedure: Amputation; Other: External herbs chitosan; Procedure: Early-stage amputation

Study type: Interventional

Funder types: Other

Identifiers

NCT02413086

ESA-EHC-DFU-2014

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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320 participants in 4 patient groups

Early-stage amputation+external herbs chitosan

Experimental group

Description:

Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.

Treatment:

Other: External herbs chitosan

Procedure: Early-stage amputation

Early-stage amputation+traditional gauze

Experimental group

Description:

Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.

Treatment:

Other: Traditional gauze

Procedure: Early-stage amputation

Amputation+external herbs chitosan

Experimental group

Description:

Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.

Treatment:

Other: External herbs chitosan

Procedure: Amputation

Amputation+traditional gauze

Experimental group

Description:

Individuals with DFU were given amputation and wound was given traditional gauze after amputation.

Treatment:

Other: Traditional gauze

Procedure: Amputation