DiabetesNCT01948037
Effectiveness Study of Hydrotherapy Against Pain and Other Symptoms in Diabetes-induced LEAD
A study testing hydrotherapy in people with Diabetes and Lower Extremity Arterial Disease, run by Jinling Hospital, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 48 to 85 years
- Conditions the study is for
- Diabetes, Lower Extremity Arterial Disease
- What is being tested?
- hydrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 diabetes mellitus
- diagnosis of lower extremity arterial disease
Who cannot join
- Severe heart disease
- can't hydrotherapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Jinling Hospital
Nanjing, Jiangsu, 210002
Jia Wei, Master, 86-025-80805491, 1736429392@qq.com
Qiu Y Bin, Bachelor
About this study
Official title: 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.
- Conditions
- Diabetes, Lower Extremity Arterial Disease
- Being tested
- hydrotherapy
- Keywords
- hydrotherapy, randomized controlled trial, lower extremity arterial disease, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrotherapyOther
30-minutes/per day,for 4weeks
hydrotherapyOther
Also called hot spring
30-minutes/per day;4weeks
| Study group | Role | What they receive |
|---|---|---|
| hydrotherapy | Active comparator | Not described Receives: Other: hydrotherapy |
| hot spring | Other | 30-minutes/per day;4weeks Receives: Other: hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the intensity of numbness and cold feeling at 4 weeks. Change from the improvement of the pain index at 4 weeks.
Measured: 4 weeks
Secondary outcomes (1)
Change from ankle-brachial index at 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiu Y bin, Study chair, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948037
- Sponsor's protocol ID
- NanjingJH
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrotherapy for the Treatment of Symptomatic Lower Extremity Arterial Disease in Diabetes Type 2 Patients:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01948037
- Acronym / sponsor ID
- NanjingJH
- Conditions
- Diabetes, Lower Extremity Arterial Disease
- Keywords
- hydrotherapy, randomized controlled trial, lower extremity arterial disease, diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate whether the hydrotherapy are effective in against pain and other symptoms in diabetes-induced LEAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrotherapy | Active comparator | Other: hydrotherapy |
| hot spring | Other | Other: hydrotherapy30-minutes/per day;4weeks |
Who may qualify
- Ages
- 48 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 diabetes mellitus
- diagnosis of lower extremity arterial disease
Key exclusion criteria (2 listed)
- Severe heart disease
- can't hydrotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrotherapy30-minutes/per day,for 4weeks | Other | hot spring, hydrotherapy |
| hydrotherapyAlso: hot spring30-minutes/per day;4weeks | Other | hot spring, hydrotherapy |
Primary outcome
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
1 secondary outcome
Change from ankle-brachial index at 4 weeks
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiu Y bin study chair
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrotherapy in people with Diabetes and Lower Extremity Arterial Disease, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.