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

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 Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Procedure: Early-stage amputation; Other: External herbs chitosan; Other: Traditional gauze; Procedure: Amputation

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early-stage amputation+external herbs chitosan; Individuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.	Procedure: Early-stage amputation; Individuals with DFU were given early-stage amputation.; Other: External herbs chitosan; Wound was given external herbs chitosan after amputation.
EXPERIMENTAL: Early-stage amputation+traditional gauze; Individuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.	Procedure: Early-stage amputation; Individuals with DFU were given early-stage amputation.; Other: Traditional gauze; Wound was given traditional gauze after amputation.
EXPERIMENTAL: Amputation+external herbs chitosan; Individuals with DFU were given amputation and wound was given herbs chitosan after amputation.	Other: External herbs chitosan; Wound was given external herbs chitosan after amputation.; Procedure: Amputation; Individuals with DFU were given amputation.
EXPERIMENTAL: Amputation+traditional gauze; Individuals with DFU were given amputation and wound was given traditional gauze after amputation.	Other: Traditional gauze; Wound was given traditional gauze after amputation.; Procedure: Amputation; Individuals with DFU were given amputation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Heilongjiang University of Chinese Medicine
• Investigators: Principal Investigator: Wang Kuang Yu, Doctor, First Affiliated Hospital of Heilongjiang UCM

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (ESTIMATE): April 9, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: diabetic foot ulcer; early-stage amputation; external therapy of herbs chitosan; wound surface healing
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: ESA-EHC-DFU-2014