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

Diabetic Foot Ulcer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02413086
• Other study ID #: ESA-EHC-DFU-2014
• Status: Not yet recruiting
• Phase: N/A
• First received: March 23, 2015
• Last updated: April 8, 2015
• Start date: April 2015

Study information

• Verified date: April 2015
• Source: Heilongjiang University of Chinese Medicine
• Contact: Wang Kuang Yu, Doctor
• Phone: +86 0451-82111401
• Email: wangkuanyu_1964[@]163.com
• Is FDA regulated: No
• Health authority: China:Ethic Committee of First Affiliated Hospital of Heilongjiang University of Chinese Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Procedure:
• Early-stage amputation
Individuals with DFU were given early-stage amputation.
• Amputation
Individuals with DFU were given amputation.

Other:
• External herbs chitosan
Wound was given external herbs chitosan after amputation.
• Traditional gauze
Wound was given traditional gauze after amputation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	Healing time	After amputation the time to heal.	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.	No
Secondary	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.	No
Secondary	Amputation level	Amputation level includes metatarsophalangeal joint, metatarsus, foot, ankle, below knee and the lower part of the thigh.	At time of surgery.	No
Secondary	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.	No
Secondary	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.	No