UnknownNot Applicable

Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot

65 participantsStarted 2016-08-17

Plain-language summary

Diabetic foot is a common complication of diabetes mellitus and requires specialized treatment. Wounds are characterized by persistent infection and chronic inflammatory processes, impeding well directed matrix remodelling and wound closure. Cold plasma applications have demonstrated beneficial effects on wound healing in several case reports. The investigator-initiated "Kaltplasma Wund (KPW)-Trial" was performed to prove beneficial effects of cold plasma in wound healing in a prospective, placebo-controlled, randomized bi-center study.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Type 1 or Type 2 Diabetes mellitus * HbA1c ≤ 10% * at least one chronic wound persisting for at least three weeks without healing tendency following standard care wound therapy (Armstrong Wagner Grade Ib or IIb) Exclusion Criteria: * concomitant wound treatment with local vacuum therapy or maggot therapy * dialysis * use of topical active antibiotics, * concomitant treatment with platelet rich fibrin, * presence of critical limb ischemia defined as ankle brachial index below 0.5 or transcutaneous oxygen pressure below 15 mmHg. * participation in another clinical trial * women of child bearing potential without effective contraception or active breastfeeding

What they're measuring

change in wound surface area

Timeframe: treatment period of max 15 days

change in signs of clinical infection

Timeframe: treatment period of max 15 days

change in microbial load

Timeframe: treatment period of max 15 days

Trial details

NCT IDNCT04205942

SponsorRuhr University of Bochum

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-20

View on ClinicalTrials.gov More Diabetic Foot trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.