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AmputationPEDNCT04018469

Patterned Electric Dressing Effects on Open Wounds

An observational study of Amputation and Open Wound, run by Gayle Gordillo at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amputation, Open Wound
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2022to Nov 2023
How long will I take part?
3 Weeks
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In this study 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Who may be able to join

  • Ages 18 years and older
  • Patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment
  • The affected limb to be amputated must have at least one open wound
  • Wound(s) must be able to be covered by 3x3 dressing
  • Subjects willing and able to provide informed consent

Who cannot join

  • Pregnant women
  • Prisoners
  • Individuals lacking consent capacity

Trial locations and contacts

1 site in 1 country.

United States1 site

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

  1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization.
  2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.
Read the detailed description

This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. Study participation is decided independent of clinical decision. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Being tested
No Interventions
Keywords
PED Wound Dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionsOther

    No Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bacterial colonization & culture

    Bacteria colonization (cultures results high, moderate, low or negative).

    Measured: 3 weeks or until amputation, whichever comes first

  2. Necrotic tissue assessed through light microscopy of tissue biopsies

    Hematoxylin and Eosin staining of tissue sections to measure extent of tissue necrosis at baseline and compared to tissue obtained at surgery after PED treatment.% necrotic tissue will be measured.

    Measured: 3 weeks or until amputation, whichever comes first

Secondary outcomes (3)

  1. Wound area measured before and after wound treatment

    To determine the effect of PED on % wound closure based on wound measurements at baseline and end of PED treatment.

    Measured: 3 weeks or until amputation, whichever comes first

  2. Bacterial biofilm through Scanning Electron Microscopy analysis

    Perform scanning electron microscopy to detect bacterial biofilm (high, moderate, low or negative) before and after PED treatment.

    Measured: 3 weeks or until amputation, whichever comes first

  3. Bacterial contamination assessed through Colony Forming Units

    Colony forming units will be measured from tissue samples and dressings to quantitate bacterial contamination levels at baseline and after PED treatment.

    Measured: 3 weeks or until amputation, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study startApr 2022 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Why it stopped: not enough staff to execute study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
Target duration
3 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT04018469
Sponsor's protocol ID
1807454805
Acronym
PED
Status last verified
Apr 2022
First submitted
11 Mar 2019
Last updated
19 Apr 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Ammons MC, Ward LS, James GA. Anti-biofilm efficacy of a lactoferrin/xylitol wound hydrogel used in combination with silver wound dressings. Int Wound J. 2011 Jun;8(3):268-73. doi: 10.1111/j.1742-481X.2011.00781.x. Epub 2011 Apr 1.

    PubMed 21457463

  • Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. doi: 10.1126/science.284.5418.1318.

    PubMed 10334980

  • Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43.

    PubMed 12825991

  • Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. doi: 10.1038/nbt0403-361. No abstract available.

    PubMed 12665817

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation and Open Wound, run by Gayle Gordillo 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 3 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: withdrawn, as of the sponsor's last update on 19 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.

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?

Bacterial colonization & culture (time frame: 3 weeks or until amputation, whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04018469, which also lists 4 linked publications.

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 19 Apr 2022.

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