Diabetic FootNCT04205942
Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot
A study testing Argon Plasma Jet in people with Diabetic Foot, run by Ruhr University of Bochum.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Argon Plasma Jet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2016to 30 Apr 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Cold Plasma Therapy for Acceleration of Wound Healing in Superficial, Infected Diabetic Foot
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.
Read the detailed description
Diabetic foot (DF) is a major complication in patients with diabetes leading to increased risk of hospitalization, lower limb amputation, and death, as well as a significant decrease in quality of life. During lifetime the risk for developing DF is assumed to be 25%; with 30% of DF resulting in lower limb amputation. If compared to general population people with diabetes have a 20-fold higher risk for amputation. Diabetes mellitus is the leading cause of lower limb amputation. Ulceration and impaired wound healing are commonly associated with common co-morbidities; the increased risk of infection amongst patients with diabetes is driving chronification and accounts for lack of wound healing.
Non-thermal atmospheric pressure plasma has been proposed as a tool for various biological and medical applications relying on its capacity to reduce bacterial load in the wound and to initiate wound healing. Biological plasma effects are largely dependent on plasma-generated reactive species in the gas phase, which subsequently diffuse or react with proteins and lipids in cells or tissues.
Thus, the objective of this placebo-controlled patient-blinded study was to show that application of cold plasma in addition to standard care treatment compared to placebo could accelerate wound healing in terms of more rapid and clinical meaningful wound surface regression. Wound closure progression and microbiological analysis were monitored time dependently to prove the effects. Patient's well-being and subjective perceptions were evaluated during treatment.
- Conditions
- Diabetic Foot
- Being tested
- Argon Plasma Jet, Placebo
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Plasma JetDevice
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.
PlaceboDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Plasma | Experimental | regular treatment with Argon Plasma Jet according to manufacturer's instructions, 8 times within 14 days Receives: 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 Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in wound surface area
change in wound surface area within 14 days treatment
Measured: treatment period of max 15 days
change in signs of clinical infection
change in clinical signs of infections as judged by the investigator
Measured: treatment period of max 15 days
change in microbial load
change in microbial count, being evaluated by microbial culture
Measured: treatment period of max 15 days
Secondary outcomes (9)
time to significant wound surface area change
time to 10% reduction of wound surface compared to treatment start
Measured: treatment period of max 15 days
total wound surface change during treatment
total wound surface change compared to treatment start
Measured: treatment period of max 15 days
time to change in wound infection
change in wound infection over treatment
Measured: treatment period of max 15 days
changes in Quality of life (EQ5D questionnaire)
Evaluation of life quality during (EQ5D questionnaire) treatment period via questionaire
Measured: treatment period of max 15 days
changes in Quality of life (SF12 questionnaire)
Evaluation of life quality during (SF12 questionnaire) treatment period via questionaire
Measured: treatment period of max 15 days
treatment related side effects - formation of keloids
question to evaluate potential side effects of the therapy: formation of keloids will be answered in a "yes" or "no" fashion and reported
Measured: treatment period of max 15 days
treatment related side effects - presence of skin irritation
question to evaluate potential side effects of the therapy: presence of skin irritation will be answered in a "yes" or "no" fashion and reported
Measured: treatment period of max 15 days
treatment related side effects - local bleeding
question to evaluate potential side effects of the therapy: local bleeding will be answered in a "yes" or "no" fashion and reported
Measured: treatment period of max 15 days
treatment related side effects - proliferative skin reaction
question to evaluate potential side effects of the therapy: proliferative skin reaction will be answered in a "yes" or "no" fashion and reported
Measured: treatment period of max 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start17 Aug 2016
- Primary completion20 Apr 2019
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diethelm Tschoepe, Ruhr University of Bochum
- Investigators
- Diethelm Tschoepe, Prof, Principal investigator, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205942
- Sponsor's protocol ID
- KPW2016-1.1
- Status last verified
- Mar 2023
- First submitted
- 12 Dec 2019
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing of patient data planned, data are analysed locally
Publications
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.
PubMed 35007358Stratmann 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.
PubMed 32672829
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Plasma Therapy for Acceleration of Wound Healing in Superficial, Infected Diabetic Foot
- ClinicalTrials.gov ID
- NCT04205942
- Acronym / sponsor ID
- KPW2016-1.1
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetic foot (DF) is a major complication in patients with diabetes leading to increased risk of hospitalization, lower limb amputation, and death, as well as a significant decrease in quality of life. During lifetime the risk for developing DF is assumed to be 25%; with 30% of DF resulting in lower limb amputation. If compared to general population people with diabetes have a 20-fold higher risk for amputation. Diabetes mellitus is the leading cause of lower limb amputation. Ulceration and impaired wound healing are commonly associated with common co-morbidities; the increased risk of infection amongst patients with diabetes is driving chronification and accounts for lack of wound healing.
Non-thermal atmospheric pressure plasma has been proposed as a tool for various biological and medical applications relying on its capacity to reduce bacterial load in the wound and to initiate wound healing. Biological plasma effects are largely dependent on plasma-generated reactive species in the gas phase, which subsequently diffuse or react with proteins and lipids in cells or tissues.
Thus, the objective of this placebo-controlled patient-blinded study was to show that application of cold plasma in addition to standard care treatment compared to placebo could accelerate wound healing in terms of more rapid and clinical meaningful wound surface regression. Wound closure progression and microbiological analysis were monitored time dependently to prove the effects. Patient's well-being and subjective perceptions were evaluated during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma | Experimental | Device: Argon Plasma Jetregular treatment with Argon Plasma Jet according to manufacturer's instructions, 8 times within 14 days |
| Placebo | Sham comparator | Device: PlaceboSham-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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argon Plasma JetCold 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. | Device | Plasma |
| PlaceboSham 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. | Device | Placebo |
Primary outcome
change in wound surface area
Time frame: treatment period of max 15 days
change in wound surface area within 14 days treatment
change in signs of clinical infection
Time frame: treatment period of max 15 days
change in clinical signs of infections as judged by the investigator
change in microbial load
Time frame: treatment period of max 15 days
change in microbial count, being evaluated by microbial culture
9 secondary outcomes
time to significant wound surface area change
Time frame: treatment period of max 15 days
total wound surface change during treatment
Time frame: treatment period of max 15 days
time to change in wound infection
Time frame: treatment period of max 15 days
changes in Quality of life (EQ5D questionnaire)
Time frame: treatment period of max 15 days
changes in Quality of life (SF12 questionnaire)
Time frame: treatment period of max 15 days
treatment related side effects - formation of keloids
Time frame: treatment period of max 15 days
treatment related side effects - presence of skin irritation
Time frame: treatment period of max 15 days
treatment related side effects - local bleeding
Time frame: treatment period of max 15 days
treatment related side effects - proliferative skin reaction
Time frame: treatment period of max 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 35007358Hiller 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.
- Derived from this study: PubMed 32672829Stratmann 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.
- Individual participant dataSharing planned: No. no sharing of patient data planned, data are analysed locally
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diethelm Tschoepe, Prof principal investigator
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Questions about this trial
What is this clinical trial studying?
A study testing Argon Plasma Jet in people with Diabetic Foot, run by Ruhr University of Bochum.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
change in wound surface area (time frame: treatment period of max 15 days). The study lists 3 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 NCT04205942, which also lists 2 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 29 Mar 2023.