Effectiveness Study of Hydrotherapy Against Pain and Othe... | NCT01948037

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

NCT01948037

Sponsor

Jinling Hospital, China

Status

Unknown status

Last Update Posted

Sep 23, 2013Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Diabetes
Lower Extremity Arterial Disease

Interventions

hydrotherapy
hydrotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 13, 2013

First Submission Date that Met QC Criteria

Sep 18, 2013

First Posted Date

Sep 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2013

Last Update Posted Date

Sep 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hydrotherapy	Active Comparator		Other: hydrotherapy
hot spring	Other	30-minutes/per day;4weeks	Other: hydrotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydrotherapy	Other	30-minutes/per day,for 4weeks	hot spring hydrotherapy

Outcomes Module

Primary Outcomes

Measure	Description	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.		4 weeks

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Change from flow velocity values at 4 weeks		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Severe heart disease
can't hydrotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

48 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qiu Y bin	Jinling Hospital, China	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Jinling Hospital	Recruiting	Nanjing	Jiangsu	210002	China

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006875	Hydrotherapy
D045482	Hot Springs

Ancestor Terms

ID	Term
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation
D060985	Natural Springs

Browse Leaves

Not provided

Browse Branches

Not provided