Venous InsufficiencyCryoNCT00617825
Feasibility Study of Cryotherapy for Chronic Venous Disorders
A study testing cyrotherapy as a cool gel wrap in people with Venous Insufficiency, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- cyrotherapy as a cool gel wrap
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2009
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 45 years and older
- CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)
- Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease
- Intact skin sensation measured with 10 gram monofilament
- Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces
- Agreement to wear compression garments such as wraps or stockings during waking hours
- Phone, e-mail, or mail accessible
- Working freezer
Who cannot join
- ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)
- Active systemic or localized infections such as cellulitis (raises skin temperature)
- Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon
- Body temperature > 37.6 degrees C (febrile state raises skin temperature)
- CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)
- Known peroneal nerve injury
Show all 12Show fewer
- Impaired skin sensation
- Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces
- Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces
- Not wearing compression or not agreeing to wear compression wraps or stockings
- Phone, e-mail, or mail inaccessible
- No working freezer
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425-1600
About this study
Official title: Cryotherapy for Chronic Venous Disorders
Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.
Read the detailed description
Chronic venous disorders (CVDs) often cause long-term disability for those who experience the worst manifestations of CVDs: disabling pain and non-healing leg ulcers. Such disabilities have significant socioeconomic implications in terms of lost work days and wages, decreased productivity,and ultimately increased health care costs that deteriorate the well-being and quality of life for those who have CVD-induced illnesses. Because no reliable preventive mechanisms exists for CVDs, this study proposes a preventive, self-management cryotherapy intervention that targets inflamed skin of populations with CVDs at highest risk of developing chronic leg ulcers. The proposed cryotherapy intervention will utilize a randomized controlled clinical trial to develop a method to reduce clinical symptoms by improving existing therapy - it is not a treatment for CVDs itself. In the proposed pilot feasibility study, subjects will be randomized to two groups; the cryotherapy intervention group (n=30) who will receive a four-week, cryotherapy gel wrap applied daily to the affected skin of the lower legs in addition to the standard of care (usual care). The control group (n=30) will receive the usual care of compression wraps or stockings applied to the lower legs and daily leg elevation. With this method, improvement of skin microcirculation, reduced leg pain, and improvement in quality of life will be observed. The following aims will test the hypothesis:
Aim 1: Evaluate the feasibility of the novel intervention including treatment fidelity, subject training, safety, and side effects associated with equipment and recruitment efforts and further refine the intervention protocol, including questionnaires used in our previous studies.
Aim 2: Estimate variability of outcome measurements and effect sizes needed to calculate sample size for a subsequent larger, adequately powered, randomized clinical trial of the efficacy of the novel cryotherapy intervention.
Aim 3: Investigate the presence of a preliminary "signal" of clinical efficacy of the experimental treatment by evaluating trends toward statistical significance for the hypothesis that the experimental group will experience greater reduction in skin temperature and blood flow, greater improvement in pain, and greater improvement in quality of life.
- Conditions
- Venous Insufficiency
- Being tested
- cyrotherapy as a cool gel wrap
- Keywords
- chronic venous disorders, cryotherapy, skin microcirculation, skin temperature
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyrotherapy as a cool gel wrapOther
Also called Elastogel Therapy Wrap
A cool gel wrap made of a hydrogel with silicon will be applied to the lower leg of skin affected by venous disorders for 30 minutes each day for 30 days during the study
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of skin microcirculation
Measured: 30 days
Secondary outcomes (2)
leg pain
Measured: 30 days
quality of life
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Teresa J Kelechi, PhD, RN, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617825
- Sponsor's protocol ID
- 17504
- Other IDs
- 1R21NR010604-01
- Acronym
- Cryo
- Status last verified
- Sep 2007
- First submitted
- 6 Feb 2008
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy for Chronic Venous Disorders
- ClinicalTrials.gov ID
- NCT00617825
- Acronym / sponsor ID
- Cryo / 17504
- Conditions
- Venous Insufficiency
- Keywords
- chronic venous disorders, cryotherapy, skin microcirculation, skin temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Feb 2008 (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.
Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.
Detailed description
Chronic venous disorders (CVDs) often cause long-term disability for those who experience the worst manifestations of CVDs: disabling pain and non-healing leg ulcers. Such disabilities have significant socioeconomic implications in terms of lost work days and wages, decreased productivity,and ultimately increased health care costs that deteriorate the well-being and quality of life for those who have CVD-induced illnesses. Because no reliable preventive mechanisms exists for CVDs, this study proposes a preventive, self-management cryotherapy intervention that targets inflamed skin of populations with CVDs at highest risk of developing chronic leg ulcers. The proposed cryotherapy intervention will utilize a randomized controlled clinical trial to develop a method to reduce clinical symptoms by improving existing therapy - it is not a treatment for CVDs itself. In the proposed pilot feasibility study, subjects will be randomized to two groups; the cryotherapy intervention group (n=30) who will receive a four-week, cryotherapy gel wrap applied daily to the affected skin of the lower legs in addition to the standard of care (usual care). The control group (n=30) will receive the usual care of compression wraps or stockings applied to the lower legs and daily leg elevation. With this method, improvement of skin microcirculation, reduced leg pain, and improvement in quality of life will be observed. The following aims will test the hypothesis:
Aim 1: Evaluate the feasibility of the novel intervention including treatment fidelity, subject training, safety, and side effects associated with equipment and recruitment efforts and further refine the intervention protocol, including questionnaires used in our previous studies.
Aim 2: Estimate variability of outcome measurements and effect sizes needed to calculate sample size for a subsequent larger, adequately powered, randomized clinical trial of the efficacy of the novel cryotherapy intervention.
Aim 3: Investigate the presence of a preliminary "signal" of clinical efficacy of the experimental treatment by evaluating trends toward statistical significance for the hypothesis that the experimental group will experience greater reduction in skin temperature and blood flow, greater improvement in pain, and greater improvement in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 45 years and older
- CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)
- Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease
- Intact skin sensation measured with 10 gram monofilament
- Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces
Key exclusion criteria (12 listed)
- ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)
- Active systemic or localized infections such as cellulitis (raises skin temperature)
- Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon
- Body temperature > 37.6 degrees C (febrile state raises skin temperature)
- CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)
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 |
|---|---|---|
| cyrotherapy as a cool gel wrapAlso: Elastogel Therapy WrapA cool gel wrap made of a hydrogel with silicon will be applied to the lower leg of skin affected by venous disorders for 30 minutes each day for 30 days during the study | Other | – |
Primary outcome
improvement of skin microcirculation
Time frame: 30 days
2 secondary outcomes
leg pain
Time frame: 30 days
quality of life
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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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.
Teresa J Kelechi, PhD, RN principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cyrotherapy as a cool gel wrap in people with Venous Insufficiency, run by Medical University of South Carolina at 1 site in United States.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jun 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of skin microcirculation (time frame: 30 days). 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 15 Jun 2018.