Peripheral Arterial DiseaseNCT06308562
Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease
A study testing Fuzzy Wale Compression Stockinet in people with Peripheral Arterial Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of this study is to determine if using Fuzzy Wale compression stockinet can assist in reducing the healing time and decrease costs in transtibial amputation patients as compared to standard of care treatment compression stocking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Fuzzy Wale Compression Stockinet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- Male and female
- Transtibial amputation expected.
- Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
- Ability of subject to give appropriate consent or have an appropriate representative available to do so.
Who cannot join
- Known allergies to any of the components of the compression.
- Terminal illness or current cancer therapy with chemotherapy
- Inability to undergo ongoing care in Rochester.
- Lack of cognitive ability to follow instructions or monitor residual limb.
- Vulnerable study population
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Vascular Research Team, (507) 538-7425
Matthew Melin, M.D., (507) 266-6717, Melin.Matthew@mayo.edu
About this study
Official title: A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
The objective of this study is to determine if using Fuzzy Wale compression stockinet can assist in reducing the healing time and decrease costs in transtibial amputation patients as compared to standard of care treatment compression stocking.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Fuzzy Wale Compression Stockinet
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzzy Wale Compression StockinetDevice
Also called EdemaWear
EdemaWear is a tubular, circular knit elastic stockinet fabricated with elastic, vertically oriented fuzzy wales, with the compression provided by the elastic, horizontal oriented Lycra® spandex yarns knitted in between. The stockinet is applied from the foot to the popliteal crease, over the affected area. EdemaWear can be applied in direct contact with the skin or over a wound care dressing. Sizing is based on leg circumference. EdemaWear is indicated for edema management of various etiologies (lymphedema, chronic venous insufficiency, congestive heart failure), and optimizing wound healing. The stockinette is often combined with other boxed compression sets. The manufacturer's stated dosage of EdemaWear is 8-12mmHg when used alone.
| Study group | Role | What they receive |
|---|---|---|
| Fuzzy Wale Compression Stockinet | Experimental | Subjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing. Receives: Device: Fuzzy Wale Compression Stockinet |
| Standard of care | No intervention | Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Number of subject presenting with surgical site infections following transtibial amputation.
Measured: 8 weeks post-operatively
Wound dehiscence
Number of subject presenting with wound dehiscence following transtibial amputation.
Measured: 8 weeks post-operatively
Pain control
Pain control during healing following transtibial amputation will be measured using the Visual Analog Scale (VAS). VAS scores range from 0-10 with 10 being the worst possible pain and 0 being no pain.
Measured: 8 weeks post-operatively
Time to prosthetic fitting
Number of days from transtibial amputation to prosthetic fitting.
Measured: 8 weeks post-operatively
Secondary outcomes (1)
Length of hospital stay
Number of days from transtibial amputation to hospital discharge.
Measured: 8 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start7 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew M. Melin, Mayo Clinic
- Investigators
- Matthew Melin, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308562
- Sponsor's protocol ID
- 23-010717
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06308562
- Acronym / sponsor ID
- 23-010717
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- 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 objective of this study is to determine if using Fuzzy Wale compression stockinet can assist in reducing the healing time and decrease costs in transtibial amputation patients as compared to standard of care treatment compression stocking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fuzzy Wale Compression Stockinet | Experimental | Device: Fuzzy Wale Compression StockinetSubjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing. |
| Standard of care | No intervention | –Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years
- Male and female
- Transtibial amputation expected.
- Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
- Ability of subject to give appropriate consent or have an appropriate representative available to do so.
Key exclusion criteria (6 listed)
- Known allergies to any of the components of the compression.
- Terminal illness or current cancer therapy with chemotherapy
- Inability to undergo ongoing care in Rochester.
- Lack of cognitive ability to follow instructions or monitor residual limb.
- Vulnerable study population
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 |
|---|---|---|
| Fuzzy Wale Compression StockinetAlso: EdemaWearEdemaWear is a tubular, circular knit elastic stockinet fabricated with elastic, vertically oriented fuzzy wales, with the compression provided by the elastic, horizontal oriented Lycra® spandex yarns knitted in between. The stockinet is applied from the foot to the popliteal crease, over the affected area. EdemaWear can be applied in direct contact with the skin or over a wound care dressing. Sizing is based on leg circumference. EdemaWear is indicated for edema management of various etiologies (lymphedema, chronic venous insufficiency, congestive heart failure), and optimizing wound healing. The stockinette is often combined with other boxed compression sets. The manufacturer's stated dosage of EdemaWear is 8-12mmHg when used alone. | Device | Fuzzy Wale Compression Stockinet |
Primary outcome
Surgical site infection
Time frame: 8 weeks post-operatively
Number of subject presenting with surgical site infections following transtibial amputation.
Wound dehiscence
Time frame: 8 weeks post-operatively
Number of subject presenting with wound dehiscence following transtibial amputation.
Pain control
Time frame: 8 weeks post-operatively
Pain control during healing following transtibial amputation will be measured using the Visual Analog Scale (VAS). VAS scores range from 0-10 with 10 being the worst possible pain and 0 being no pain.
Time to prosthetic fitting
Time frame: 8 weeks post-operatively
Number of days from transtibial amputation to prosthetic fitting.
1 secondary outcome
Length of hospital stay
Time frame: 8 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Matthew Melin, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuzzy Wale Compression Stockinet in people with Peripheral Arterial Disease, run by Mayo Clinic 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vascular Research Team ((507) 538-7425, Melin.Matthew@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 8 weeks post-operatively). The study lists 4 primary outcomes in all. 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 14 Jan 2026.