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

September 18, 2013 updated by: Nanjing Jinling Hospital

Hydrotherapy for the Treatment of Symptomatic Lower Extremity Arterial Disease in Diabetes Type 2 Patients:A Randomized Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Nanjing Jinling Hospital
        • Contact:
        • Principal Investigator:
          • Qiu Y Bin, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Type 2 diabetes mellitus
  • diagnosis of lower extremity arterial disease

Exclusion Criteria:

  • Severe heart disease
  • can't hydrotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from the intensity of numbness and cold feeling at 4 weeks. Change from the improvement of the pain index at 4 weeks.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from ankle-brachial index at 4 weeks
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change from flow velocity values at 4 weeks
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Jinling Hospital

Investigators

  • Study Chair: Qiu Y bin, Nanjing Jinling Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (ESTIMATE)

September 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanjingJH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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