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Diabetic Foot UlcerNCT02413086

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

A study testing Early-stage amputation, Amputation and External herbs chitosan in people with Diabetic Foot Ulcer, run by Heilongjiang University of Chinese Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 17 to 70 years
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Early-stage amputation, Amputation and External herbs chitosan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
No sites listed yet
Study dates
Apr 2015to Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • According to Chinese herbs medicine standard for the diagnosis and treatment of diabetic foot, the individual diagnosed as diabetic foot with acromelic gangrene.
  • The individual aged between 18 and 70 years.
  • All wounds corresponded to Wagner classification grade 4 or 5.
  • By appropriate treatment, skin temperature of limb with ulcer became warmer and it proved that the blood circulation recovery could be happening.
  • There were no obvious bruises or chromatosis in the necrosis skin.
  • Persistent limb pain affected the sleep of the individuals.
  • The individual voluntarily signed the informed consent form.

Who cannot join

  • Acromelic gangrene caused by other reasons.
  • The individuals with server cardiovascular and cerebrovascular diseases or hepatic and kidney diseases do not adhere to surgery.
  • The individuals with the history of amputation.
  • The individuals with systemic inflammatory response syndrome, Bacteremia, Pyemia or shock.
  • Vascular ultrasound shows artery is completely blocked.
  • The individuals do not adhere to the treatment or are with other treatments.

Trial locations and contacts

No sites are listed yet.

Wang Kuang Yu, Doctor contact

+86 0451-82111401

wangkuanyu_1964@163.com

About this study

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.

Being tested
Early-stage amputation, Amputation, External herbs chitosan, Traditional gauze
Keywords
diabetic foot ulcer, early-stage amputation, external therapy of herbs chitosan, wound surface healing
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early-stage amputationProcedure or surgery

    Individuals with DFU were given early-stage amputation.

  • AmputationProcedure or surgery

    Individuals with DFU were given amputation.

  • External herbs chitosanOther

    Wound was given external herbs chitosan after amputation.

  • Traditional gauzeOther

    Wound was given traditional gauze after amputation.

Study groups in NCT02413086
Study groupRoleWhat they receive
Early-stage amputation+external herbs chitosanExperimentalIndividuals with DFU were given early-stage amputation and wound was given herbs chitosan after amputation.
Receives: Procedure: Early-stage amputation; Other: External herbs chitosan
Early-stage amputation+traditional gauzeExperimentalIndividuals with DFU were given early-stage amputation and wound was given traditional gauze after amputation.
Receives: Procedure: Early-stage amputation; Other: Traditional gauze
Amputation+external herbs chitosanExperimentalIndividuals with DFU were given amputation and wound was given herbs chitosan after amputation.
Receives: Procedure: Amputation; Other: External herbs chitosan
Amputation+traditional gauzeExperimentalIndividuals with DFU were given amputation and wound was given traditional gauze after amputation.
Receives: Procedure: Amputation; Other: Traditional gauze

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The re-operation rate

    Because of diabetic foot ulcer individual was given a re-operation.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

  2. Grades of wound healing

    As wound healing, wound healing was assessed using 1 to 3 healing grades.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Secondary outcomes (5)

  1. Healing time

    After amputation the time to heal.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

  2. The rate of infection

    After amputation, there was infection or no infection in the wound.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

  3. Amputation level

    Amputation level includes metatarsophalangeal joint, metatarsus, foot, ankle, below knee and the lower part of the thigh.

    Measured: At time of surgery.

  4. Trinity amputation and prosthesis experience scale (TAPES)

    Measured: 7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.

  5. SF-36

    The medical outcomes study 36-item short form health survey

    Measured: 7 days of amputation, 14 days of amputation, 1 month of amputation, 3 months of amputation and 6 months of amputation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02413086
Sponsor's protocol ID
ESA-EHC-DFU-2014
Status last verified
Apr 2015
First submitted
23 Mar 2015
Last updated
9 Apr 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 16291063

  • 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.

    PubMed 25573978

  • 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.

    PubMed 20578276

  • 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.

    PubMed 21949231

  • 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.

    PubMed 12644975

Questions about this trial

What is this clinical trial studying?

A study testing Early-stage amputation, Amputation and External herbs chitosan in people with Diabetic Foot Ulcer, run by Heilongjiang University of Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wang Kuang Yu, Doctor (+86 0451-82111401, wangkuanyu_1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The re-operation rate (time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02413086, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.

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