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Effectiveness Study of Hydrotherapy Against Pain and Other Symptoms in Diabetes-induced LEAD

Sponsor
Nanjing Jinling Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01948037
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
23
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate whether the hydrotherapy are effective in against pain and other symptoms in diabetes-induced LEAD.

Condition or Disease Intervention/Treatment Phase
  • Other: hydrotherapy
  • Other: hydrotherapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hydrotherapy for the Treatment of Symptomatic Lower Extremity Arterial Disease in Diabetes Type 2 Patients:A Randomized Controlled Trial
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: hydrotherapy

Other: hydrotherapy
30-minutes/per day,for 4weeks

Other: hydrotherapy
30-minutes/per day;4weeks
Other Names:
  • hot spring

    		•
    Other: hot spring

    30-minutes/per day;4weeks

    Other: hydrotherapy
    30-minutes/per day,for 4weeks

    Other: hydrotherapy
    30-minutes/per day;4weeks
    Other Names:
  • hot spring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from the intensity of numbness and cold feeling at 4 weeks. Change from the improvement of the pain index at 4 weeks. [4 weeks]

    Secondary Outcome Measures

    1. Change from ankle-brachial index at 4 weeks [4 weeks]

    Other Outcome Measures

    1. Change from flow velocity values at 4 weeks [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    48 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of Type 2 diabetes mellitus

    • diagnosis of lower extremity arterial disease

    Exclusion Criteria:

    • Severe heart disease

    • can't hydrotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Jinling Hospital Nanjing Jiangsu China 210002

    Sponsors and Collaborators

    • Nanjing Jinling Hospital

    Investigators

    • Study Chair: Qiu Y bin, Nanjing Jinling Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanjing Jinling Hospital
    ClinicalTrials.gov Identifier:
    NCT01948037
    Other Study ID Numbers:
    • NanjingJH
    First Posted:
    Sep 23, 2013
    Last Update Posted:
    Sep 23, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Nanjing Jinling Hospital
    hydrotherapy
    randomized controlled trial
    lower extremity arterial disease
    diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of Sep 23, 2013