NCT01948037

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 23, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

September 13, 2013

Last Update Submit

September 18, 2013

Conditions

DiabetesLower Extremity Arterial Disease

Keywords

hydrotherapyrandomized controlled triallower extremity arterial diseasediabetes

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Change from ankle-brachial index at 4 weeks

    4 weeks

Other Outcomes (1)

  • Change from flow velocity values at 4 weeks

    4 weeks

Study Arms (2)

hydrotherapy

ACTIVE COMPARATOR
Other: hydrotherapy

hot spring

OTHER

30-minutes/per day;4weeks

Other: hydrotherapy

Interventions

hydrotherapyOTHER

30-minutes/per day,for 4weeks

hot springhydrotherapy

Eligibility Criteria

Age48 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe heart disease
  • can't hydrotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

HydrotherapyHot Springs

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationNatural SpringsGroundwaterGeological PhenomenaPhysical PhenomenaExtreme EnvironmentsEnvironmentEcological and Environmental PhenomenaBiological Phenomena

Study Officials

  • Qiu Y bin

    Jinling Hospital, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2013

First Posted

September 23, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 23, 2013

Record last verified: 2013-08

Locations

CN(1)