Chronic Skin UlcerPRF-TATNCT02652169
PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4
A study testing PRF mixed with amikacin and teicoplanin, PRF mixed with PHMB plus Macrogolol and PRF plus normal saline in people with Chronic Skin Ulcer, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven therapeutic efficacy. This randomised controlled trial aims to provide evidence of the efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial compounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Skin Ulcer
- What is being tested?
- PRF mixed with amikacin and teicoplanin, PRF mixed with PHMB plus Macrogolol and PRF plus normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged over 18 who are able to give informed consent
- Chronic venous ulcer with localized non-systemic soft-tissue infection diagnosed by senior infectious diseases specialist based on US FDA Guidance for Industry Chronic cutaneous ulcer and burn wounds June 2006:
- slough and necrotic tissue
- exsudate
- smell
- inflammation
Show all 9Show fewer
- presence of granulation tissue
- pain
- Wound size ≥ 5 cm2 and < 200 cm2
Who cannot join
- Non-treated diabetes mellitus, HbA1c > 12 mg/dl
- Non treated (orthopaedic shoe) diabetic foot syndrome
- ABI < 0,7
- Wound size 15 cm2 and > 200 cm2
- CRP > 5 mg/dl
- Leucocytes > 15.000 /μl
Show all 25Show fewer
- Infection of another site
- Infection of the ulcer with a pathogen with inherent resistance to amikacin and teicoplanin
- Known osteomyelitis
- Known erysipelas
- Known phlegmon
- Complicated deep tissue infection not solely treatable with PRF plus antimicrobial therapy in the opinion of a senior infectious diseases specialist
- Planned systemic antimicrobial therapy
- Active viral hepatitis (A/B/C) or active HIV infection or active syphilis
- Increased sensitivity to amikacin or teicoplanin, PHMB or macrogolol
- Increased sensitivity to tramexanic acid or batroxobin
- Presence of neoplastic growth in the ulcer
- Thrombocytopenic patients (<150.000 G/L)
- Haemoglobin < 95 g/L
- Known pregnancy or lactation
- Severe renal impairment (creatinine clearance <30 ml/min)
- History or clinical signs of impairment of the cochlea or vestibularis system
- Neuromuscular diseases (i.e. Myasthenia gravis, Parkinson's disease)
- Aminoglycoside treatment less than four weeks before inclusion
- Other reasons opposing the study participation on the discretion of the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Florian Thalhammer, Prof. Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1190
Florian Thalhammer, Prof. MD, 0043140400 ext. 4440, florian.thalhammer@meduniwien.ac.at
Florian Thalhammer, Prof. MD
About this study
Official title: Platelet Rich Fibrin in Combination With Topical Antibiotics or Antiseptics in the Treatment of Chronic Wounds - a Prospective, Randomized, Active Controlled, Double Blind Pilot Trial With an Observer-blinded Control Group
Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven therapeutic efficacy. This randomised controlled trial aims to provide evidence of the efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial compounds. The investigators therefore designed a four armed trial with three PRF arms which are compared to each other as well as to an active comparator. The treatment arms are as follows:
Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4: Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be included in this trial. Infection shall be diagnosed by an experienced senior infectious diseases specialist. Patients with untreated peripheral vascular occlusive disease as defined by an ABI (ancle brachial index) of < 0,7 are excluded from the trial as are patients with an uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a diabetic foot syndrome. Any underlying illness will be treated following standard of care. In case of chronic venous insufficiency four-layered compression bandages will be applied each visit if tolerated by the patient. Alternatively compression stockings (Class III) are permitted. This is mentioned as "Disease specific treatment" in the protocol.
Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious diseases specialist.
- Conditions
- Chronic Skin Ulcer
- Being tested
- PRF mixed with amikacin and teicoplanin, PRF mixed with PHMB plus Macrogolol, PRF plus normal saline, Silver gauze
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF mixed with amikacin and teicoplaninDrug
Also called PRF plus amikacin/teicoplanin
PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer
PRF mixed with PHMB plus MacrogololDrug
Also called PRF plus Lavasorb
PRF, mixed with Lavasorb is applied to the chronic ulcer
PRF plus normal salineDrug
Also called PRF plus sodium chloride 0.9%
PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer
Silver gauzeOther
Also called Acticoat 7
Acticoat 7 silver wound dressing is applied to the chronic ulcer
| Study group | Role | What they receive |
|---|---|---|
| Study arm 1 - PRF plus amikacin and teicoplanin | Experimental | PRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer Receives: Drug: PRF mixed with amikacin and teicoplanin |
| Study arm 2 - PRF plus normal saline | Experimental | PRF mixed with normal saline is sprayed on the patients' ulcer Receives: Drug: PRF plus normal saline |
| Study arm 3 - PRF mixed with PHMB plus Macrogolol | Experimental | PRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer Receives: Drug: PRF mixed with PHMB plus Macrogolol |
| Study arm 4 - Acticoat 7 | Active comparator | A silver gauze (Acticoat 7®) is applied to the patients' ulcer Receives: Other: Silver gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in wound area
Measured: day 56
Secondary outcomes (6)
Number of patients in necessity to initiate systemic antimicrobial therapy based on the opinion of a senior infectious disease consultant arises (subjective assessment based on wound inflammation, serum c-reactive protein levels and leucocyte count)
Measured: day 0, 7, 14, 21, 28, 35, 42, 49, 56
Elevation of C-reactive protein over 7 mg/dl (normal value 0.5 mg/dl)
Measured: day 0, 7, 14, 21, 28, 35, 42, 49, 56
time to sterility of the wound
Measured: day 0, 7, 14, 21, 28, 35, 42, 49, 56
Relative wound volume and wound area reduction
Measured: on day 28 and 56
Occurrence of drug resistant bacteria in the wound
Measured: day 0, 7, 14, 21, 28, 35, 42, 49, 56
Occurrence of drug resistant bacteria in a swab of the tissue surrounding the wound or a Z-swab of the torso
Measured: on day 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2025 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Skin UlcerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Thalhammer, Medical University of Vienna
- Investigators
- Florian Thalhammer, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652169
- Sponsor's protocol ID
- PRF-TAT
- Acronym
- PRF-TAT
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin in Combination With Topical Antibiotics or Antiseptics in the Treatment of Chronic Wounds - a Prospective, Randomized, Active Controlled, Double Blind Pilot Trial With an Observer-blinded Control Group
- ClinicalTrials.gov ID
- NCT02652169
- Acronym / sponsor ID
- PRF-TAT / PRF-TAT
- Conditions
- Chronic Skin Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Jan 2016 (estimated)
- 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.
Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven therapeutic efficacy. This randomised controlled trial aims to provide evidence of the efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial compounds. The investigators therefore designed a four armed trial with three PRF arms which are compared to each other as well as to an active comparator. The treatment arms are as follows:
Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4: Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be included in this trial. Infection shall be diagnosed by an experienced senior infectious diseases specialist. Patients with untreated peripheral vascular occlusive disease as defined by an ABI (ancle brachial index) of < 0,7 are excluded from the trial as are patients with an uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a diabetic foot syndrome. Any underlying illness will be treated following standard of care. In case of chronic venous insufficiency four-layered compression bandages will be applied each visit if tolerated by the patient. Alternatively compression stockings (Class III) are permitted. This is mentioned as "Disease specific treatment" in the protocol.
Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious diseases specialist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study arm 1 - PRF plus amikacin and teicoplanin | Experimental | Drug: PRF mixed with amikacin and teicoplaninPRF mixed with amikacin and teicoplanin is sprayed on the patients' ulcer |
| Study arm 2 - PRF plus normal saline | Experimental | Drug: PRF plus normal salinePRF mixed with normal saline is sprayed on the patients' ulcer |
| Study arm 3 - PRF mixed with PHMB plus Macrogolol | Experimental | Drug: PRF mixed with PHMB plus MacrogololPRF mixed with polyhexanide and macrogolol is sprayed on the patients' ulcer |
| Study arm 4 - Acticoat 7 | Active comparator | Other: Silver gauzeA silver gauze (Acticoat 7®) is applied to the patients' ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females aged over 18 who are able to give informed consent
- Chronic venous ulcer with localized non-systemic soft-tissue infection diagnosed by senior infectious diseases specialist based on US FDA Guidance for Industry Chronic cutaneous ulcer and burn wounds June 2006:
- Wound size ≥ 5 cm2 and < 200 cm2
Key exclusion criteria (25 listed)
- Non-treated diabetes mellitus, HbA1c > 12 mg/dl
- Non treated (orthopaedic shoe) diabetic foot syndrome
- ABI < 0,7
- Wound size 15 cm2 and > 200 cm2
- CRP > 5 mg/dl
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 |
|---|---|---|
| PRF mixed with amikacin and teicoplaninAlso: PRF plus amikacin/teicoplaninPRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer | Drug | Study arm 1 - PRF plus amikacin and teicoplanin |
| PRF mixed with PHMB plus MacrogololAlso: PRF plus LavasorbPRF, mixed with Lavasorb is applied to the chronic ulcer | Drug | Study arm 3 - PRF mixed with PHMB plus Macrogolol |
| PRF plus normal salineAlso: PRF plus sodium chloride 0.9%PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer | Drug | Study arm 2 - PRF plus normal saline |
| Silver gauzeAlso: Acticoat 7Acticoat 7 silver wound dressing is applied to the chronic ulcer | Other | Study arm 4 - Acticoat 7 |
Primary outcome
reduction in wound area
Time frame: day 56
6 secondary outcomes
Number of patients in necessity to initiate systemic antimicrobial therapy based on the opinion of a senior infectious disease consultant arises (subjective assessment based on wound inflammation, serum c-reactive protein levels and leucocyte count)
Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56
Elevation of C-reactive protein over 7 mg/dl (normal value 0.5 mg/dl)
Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56
time to sterility of the wound
Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56
Relative wound volume and wound area reduction
Time frame: on day 28 and 56
Occurrence of drug resistant bacteria in the wound
Time frame: day 0, 7, 14, 21, 28, 35, 42, 49, 56
Occurrence of drug resistant bacteria in a swab of the tissue surrounding the wound or a Z-swab of the torso
Time frame: on day 28 and 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Skin Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
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.
Florian Thalhammer, Prof. Dr. contact
Florian Thalhammer, Prof. Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF mixed with amikacin and teicoplanin, PRF mixed with PHMB plus Macrogolol and PRF plus normal saline in people with Chronic Skin Ulcer, run by Medical University of Vienna at 1 site in Austria.
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 9 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Thalhammer, Prof. Dr. (0043140400 ext. 44400), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in wound area (time frame: day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.