NCT04689620

Brief Summary

There will be different effects for different laser wavelengths in treatment of venous ulcer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

December 26, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

2 days

First QC Date

December 22, 2020

Last Update Submit

December 27, 2020

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

  • wound surface area

    measuring the ulcer surface area by smart phone application

    two months

  • number of bacteria in wound

    measuring number of bacteria by colony count

    two months

Study Arms (3)

HELIUM NEON LASER plus regular ulcer care

EXPERIMENTAL

laser scanning the wound with 9.6 jole/cm2 then regular dressing

Device: laser

GALLIUM ARSENIDE plus regular ulcer care

EXPERIMENTAL

laser scanning the wound with 9.6 jole/cm2 then regular dressing

Device: laser

regular ulcer care

ACTIVE COMPARATOR

dressing for the ulcer

Device: laser

Interventions

laserDEVICE

treating the venous ulcer with laser

GALLIUM ARSENIDE plus regular ulcer careHELIUM NEON LASER plus regular ulcer careregular ulcer care

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients approximately the same age (50-60).
  • All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
  • All patients with conscious.

You may not qualify if:

  • All patients had no diabetes or blood problems.
  • any immunity disorder affect wound heaing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Lasers

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 30, 2020

Study Start

December 26, 2020

Primary Completion

December 28, 2020

Study Completion

February 1, 2021

Last Updated

December 30, 2020

Record last verified: 2020-12