Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot

NCT04205942 | Unknown

• 1 other identifier: KPW2016-1.1
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (3)

• change in wound surface area

  change in wound surface area within 14 days treatment

  treatment period of max 15 days

• change in signs of clinical infection

  change in clinical signs of infections as judged by the investigator

  treatment period of max 15 days

• change in microbial load

  change in microbial count, being evaluated by microbial culture

  treatment period of max 15 days

Secondary Outcomes (9)

• time to significant wound surface area change

  treatment period of max 15 days

• total wound surface change during treatment

  treatment period of max 15 days

• time to change in wound infection

  treatment period of max 15 days

• changes in Quality of life (EQ5D questionnaire)

  treatment period of max 15 days

• changes in Quality of life (SF12 questionnaire)

  treatment period of max 15 days

Other Outcomes (4)

• treatment related side effects - formation of keloids

  within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)

• treatment related side effects - presence of skin irritation

  within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)

• treatment related side effects - local bleeding

  within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)

Study Arms (2)

Plasma

EXPERIMENTAL

regular treatment with Argon Plasma Jet according to manufacturer's instructions, 8 times within 14 days

Device: Argon Plasma Jet

Placebo

SHAM COMPARATOR

Sham-treatment with Argon Plasma Jet, Plasma producing electric field switched off - no Plasma is produced, just argon gas as effluent, 8 times within 14 days

Device: Placebo

Interventions

Argon Plasma Jet DEVICE

Cold Plasma (CP) therapy is applied in the first week of treatment on a daily schedule, in the second week CP is applied every second day. In total, 8 applications are performed with a one day schedule variance.

Plasma

Placebo DEVICE

Sham Cold Plasma (sham-CP) (switched off Electric field, no plasma production, just gas) therapy is applied in the first week of treatment on a daily schedule, in the second week sham-CP is applied every second day. In total, 8 applications are performed with a one day schedule variance.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Related Publications (2)

• Hiller J, Stratmann B, Timm J, Costea TC, Tschoepe D. Enhanced growth factor expression in chronic diabetic wounds treated by cold atmospheric plasma. Diabet Med. 2022 Jun;39(6):e14787. doi: 10.1111/dme.14787. Epub 2022 Jan 21.

  PMID: 35007358 DERIVED

• Stratmann B, Costea TC, Nolte C, Hiller J, Schmidt J, Reindel J, Masur K, Motz W, Timm J, Kerner W, Tschoepe D. Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jul 1;3(7):e2010411. doi: 10.1001/jamanetworkopen.2020.10411.

  PMID: 32672829 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Diethelm Tschoepe, Prof

  Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. med., Medical Director Diabetes Center at Herz- und Diabeteszentrum NRW

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 20, 2019
• Study Start: August 17, 2016
• Primary Completion: April 20, 2019
• Study Completion: April 30, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share