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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01948037
• Other study ID #: NanjingJH
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2013
• Last updated: September 18, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: Nanjing Jinling Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 48 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Type 2 diabetes mellitus

• diagnosis of lower extremity arterial disease

Exclusion Criteria:

• Severe heart disease

• can't hydrotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Lower Extremity Arterial Disease

Intervention

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

Locations

Country	Name	City	State
China	Nanjing Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Jinling Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from flow velocity values at 4 weeks		4 weeks	Yes
Primary	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	Yes
Secondary	Change from ankle-brachial index at 4 weeks		4 weeks	Yes