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Low-Temperature Atmospheric Pressure Plasma as an Adjunctive Therapy for Diabetic Foot Ulcers: A Randomized Comparative Study of Healing Outcomes, Bacterial Reduction and Cost-Effectiveness

Low-Temperature Atmospheric Pressure Plasma as an Adjunctive Therapy for Diabetic Foot Ulcers: A Randomized Comparative Study of Healing Outcomes, Bacterial Reduction and Cost-Effectiveness

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260903005
Enrollment
60
Registered
2026-09-03
Start date
2022-01-08
Completion date
Unknown
Last updated
2026-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This randomized comparative clinical study enrolled adult patients aged 18-80 years with Wagner-Meggitt grade 1-3 DFUs. Participants received either SOC wound management or SOC without topical anibiotic plus LTAPP using a standardized protocol. Patients were followed for up to 16 weeks or until healing/coverage. Outcomes included healed wounds, wound area reduction, wound volume reduction, exudate reduction, granulation tissue formation, necrotic tissue reduction, bacterial load reduction, time

Interventions

Both groups received standard wound management, including wound cleansing with normal saline and debridement when clinically indicated. Dressing selection was determined by wound exudate level and inf
standard of wound care ,LTAPP

Sponsors

Thailand center of excellence for life science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.diabetic foot patients age 18-8 yrs

Exclusion criteria

Exclusion criteria: 1. severe underlying disease such as CKD, sepsis 2.patients can not complete treatment 3.cancer patients 4.previous RT or on immunosuppressive drug 5.pregnancy or breast feeding 6.patients receive other treatment 7.patients had coagulopathy

Design outcomes

Primary

MeasureTime frame
wound healing every 2 wk until visit 10 cmsqure/ and calculate by program—

Secondary

MeasureTime frame
bacterial reduction every 2 wk until visit 10 few, moderated /culture report ,cost effective at 16th weeks US dollar / total cost in data sheet record—

Countries

Thailand

Contacts

Public Contactatthawit mongkornwong

prince of sonkla university

atthawit.sx@gmail.com0855856980

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Oct 17, 2026