Wound Chronic DrainingPhase 2NCT07318792
Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to Treat Chronic Non-Healing Wounds
A Phase 2 study testing Platelet-rich fibrin (PRF) in people with Wound Chronic Draining and Wound Closure, run by Estar Medical dba Medical Technologies, LTD at 3 sites in United States.
Trial summary
Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Chronic Draining, Wound Closure
- What is being tested?
- Platelet-rich fibrin (PRF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female ≥ 18≤ 80 years of age 2. Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ulcer, pressure ulcer, or mechanically or surgically debrided.
- 3. Located in any anatomical location on the body. 4. If more than one non-healing wound is present, an index wound will be selected ≥ 1.0 cm2 size and less than or equal to 25.0 cm2.
- 5. If the wound is in an ulcer cluster the dominant ulcer will be selected, with at least 2.0 cm2 between the index wound and other wounds.
- 6. The study wound will be present for at least thirty (30) days and the subject will have undergone standard of care assessment and intervention, according to the wound type being evaluated, where SOC may include, but not be limited to, proper cleansing and debridement, off-loading, compression, bioburden reduction, moisture management, infection control, optimized perfusion, venous ablation, nutrition supplementation, smoking cessation counseling and medical therapy, and access to wound and underlying disease education and training.
- 7. Neurovascular assessment, conducted according to the assessment typically performed for the wound type will be performed during Screening (Study Visit 1), and repeated at the level normally conducted at the follow-up visits. Perfusion should be adequate to sustain a healing process. Neurological examinations will be performed to document the presence of neuropathy and/or nerve injury.
- 8. Documented 40% or less wound closure during thirty (30) days of standard of care (SOC).
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- 9. No clinical signs of infection at the wound site or the affected limb. 10. Post-debridement with no residual necrotic tissue. 11. Platelet counts should be within normal range ≥ 105,000 to <450, 000. 12. Hemoglobin (Hgb) ≥ 10 g/dL and Hematocrit (HCT) ≥ 27%. 13. HbA1C ≤ 12%. 14. Chronic renal failure (CRF) and dialysis patients may be enrolled. 15. PT/aPTT/INR should be within normal limits unless the subject is on coumadin, then maintain range of INR 2 to 3.
- 16. Prealbumin ≥ 15 mg/dL. 17. Adequate off-loading of the wound site for wheelchair bound, bed bound, and ambulatory subjects.
- 18. Multi-layered compression dressings for venous related wounds. 19. Females of childbearing potential should not be pregnant and agree to avoid conceiving during the study.
- 20. Males agree to use contraception or abstinence during the study. 21. The subject has provided written informed consent prior to any screening procedures and agrees to comply with study procedures and requirements.
- 22. Usual care therapies that may be included will be negative pressure wound therapy (NPWT), antimicrobial dressings, collagen containing matrix and packing materials.
Who cannot join
- Life expectancy is less than twelve (12) months.
- Participation in another clinical trial involving an investigational device or drug within thirty (30) days prior to enrollment.
- Sepsis within two (2) weeks prior to enrollment.
- Soft tissue infection affecting the wound within two (2) weeks prior to enrollment.
- Known osteomyelitis or occult osteomyelitis documented with inflammatory markers ESR ≥ 60 and/or CRP ≥7.9 mg/dL.
- Religious constraints to using blood products, including autologous blood.
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- Alcohol or substance abuse (other than tobacco) within 2 months prior.
- Severe lymphedema at Stage 3b or greater (lymphostatic elephantiasis).
- The inability to use compression therapy for venous insufficiency or lymphedema.
- Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
- Hemophilia, sickle cell anemia, thrombocytopenia, and leukemia or blood dyscrasia.
- History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin, intravenously. However, subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.
- Cytostatic therapy within the past 12 months.
- The subject has inadequate venous access for repeated blood draw.
- Known HBV, HCV, or HIV.
- Blood-borne or communicable disease that would likely prevent full participation in the trial (HIV, AIDS, COVID-19).
- Subjects with known sensitivity to blood components of the PRF Kit (e.g., rubber stopper, vacutainer tubing).
- Advanced therapy treatments with hyperbaric oxygen, electrical stimulation (eStim), pulsed electromagnetic energy fields (PEMF), colored light therapies, cellular tissue products (CTPs) like amniotic tissues, Apligraf® and Dermagraft® will be excluded; while NPWT, collagen matrix products (sheet or bulk packing), antimicrobial dressings (surfactants, silver or copper, hypochlorous acid) may be used.
- AIDS- acquired immunodeficiency syndrome; COPD-chronic obstructive pulmonary disease; COVID-19- Coronavirus Disease-19; CRP- C-reactive protein; ESR-erythrocyte sedimentation rate; HBV-hepatitis B virus; HCV- hepatitis C virus; HIV- human immune-deficiency virus.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
MCR Health-Advanced Specialty Institute (ASI)
Bradenton, Florida, 34209
Chrisbel N Dafeamekpor, DPM, 941-304-3971, cdafeamekpor@mcr.health
Evelyn Perez, CRA, 941-304-9885, eperez2@mcr.health
San Antonio Vascular and Endovascular Clinic (SAVE)
San Antonio, Texas, 78221
The San Antonio Vascular and Endovascular Clinic (SAVE)
San Antonio, Texas, 78221
Elizabeth Knight, CCRC, 941-304-3971, eknight@flourishresearch.com
Nolan Payton, CCRC, 409-550-3145, npayton@flourishresearch.com
About this study
Official title: Evaluation of the Safety and the Clinical Effectiveness of Using Tropocells® Autologous PRF System to Treat Chronic, Non-healing, Non-infected Wounds in Combination With Standard of Care (SOC).
Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. This will help determine the safety and effective use of PRF in the treatment of soft tissue defects.
Read the detailed description
Chronic wounds are wounds that fail to progress through a normal healing process in a timely fashion. Typically the wounds remain in a pro-inflammatory state. The activation of platelets reacting to tissue damage initiates most healing sequences. The use of activated platelets in the form or platelet-rich plasma (PRP) and/or platelet-rich fibrin (PRF) applied to a clean wound base has been associated with improved wound healing outcomes for bony and soft tissues, especially when associated with standard of care (SOC), including supporting underlying medical conditions, improved perfusion and oxygenation, edema control, removing recurrent insults for trauma, treating infection, and preventing ongoing inflammatory triggers. Activated platelets in the form of Tropocells(R) autologous platelet-rich fibrin (PRF) made from "blood drawn from peripheral veins, and centrifuged into a gel, topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds." Sixteen (16) Subjects will be enrolled to evaluate the efficacy and safety when used to treat chronic noninfected, nonhealing, mild to moderately ischemic wounds.
- Conditions
- Wound Chronic Draining, Wound Closure
- Being tested
- Platelet-rich fibrin (PRF)
- Keywords
- Chronic Non-healing Wounds, TropoCells(R) Platelet-rich Fibrin (PRF), Autologous Platelet-rich Fibrin (PRF), Platelet Derived Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Device
Standard of Care will include-
- Nutritional Supplementation using 14 days Juven(R)
- Wound Cleansing and Debridement
- Mild to Moderate Compression as needed for edema Control
- Off-loading as needed (foot gear, chair cushions, bed mattresses)
- Antimicrobial Dressings as needed
- Edema Control
- Negative Pressure Wound Therapy- as needed
- Collagen dressings as indicated
- Optimized perfusion/oxygenation
- Treated Underlying Medical Conditions
| Study group | Role | What they receive |
|---|---|---|
| Participants with non-infected, mild-to-moderate, chronic open soft tissue wound | Active comparator | Tropocells® Autologous Platelet-Rich Fibrin (PRF) to be topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically debrided wounds", intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional. Receives: Device: Platelet-rich fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
Number of Subjects with Complete Wound Closure- defined as 100% re-epithelialization remaining closed during two (2) consecutive weekly follow-up assessments.
- Intent-to-treat analysis
- Per-protocol analysis
Measured: From Screening to end of follow-up at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound Chronic DrainingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Estar Medical dba Medical Technologies, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Clinical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318792
- Sponsor's protocol ID
- RND054- AIM II Chronic Wounds
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual Participant Data will be shared with the FDA in support of the IDE, if required. There is no plan to share IPD with journals or publications.
Publications
Bolton L. Platelet-Rich Plasma: Optimal Use in Surgical Wounds. Wounds. 2021 Aug;33(8):219-221.
PubMed 34357880Milek T, Nagraba L, Mitek T, Wozniak W, Mlosek K, Olszewski W, Ciostek P, Deszczynski J, Kuchar E, Stolarczyk A. Autologous Platelet-Rich Plasma Reduces Healing Time of Chronic Venous Leg Ulcers: A Prospective Observational Study. Adv Exp Med Biol. 2019;1176:109-117. doi: 10.1007/5584_2019_388.
PubMed 31134552Qu W, Wang Z, Hunt C, Morrow AS, Urtecho M, Amin M, Shah S, Hasan B, Abd-Rabu R, Ashmore Z, Kubrova E, Prokop LJ, Murad MH. The Effectiveness and Safety of Platelet-Rich Plasma for Chronic Wounds: A Systematic Review and Meta-analysis. Mayo Clin Proc. 2021 Sep;96(9):2407-2417. doi: 10.1016/j.mayocp.2021.01.030. Epub 2021 Jul 3.
PubMed 34226023Meznerics FA, Fehervari P, Dembrovszky F, Kovacs KD, Kemeny LV, Csupor D, Hegyi P, Banvolgyi A. Platelet-Rich Plasma in Chronic Wound Management: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Clin Med. 2022 Dec 19;11(24):7532. doi: 10.3390/jcm11247532.
PubMed 365561511. Wounds International: White paper on wound balance - Achieving wound healing with confidence (2023), https://woundsinternational.com/wp-content/uploads/2023/04/HAR23_Supp_Wound-Balance_WINT-Web.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and the Clinical Effectiveness of Using Tropocells® Autologous PRF System to Treat Chronic, Non-healing, Non-infected Wounds in Combination With Standard of Care (SOC).
- ClinicalTrials.gov ID
- NCT07318792
- Acronym / sponsor ID
- RND054- AIM II Chronic Wounds
- Conditions
- Wound Chronic Draining, Wound Closure
- Keywords
- Chronic Non-healing Wounds, TropoCells(R) Platelet-rich Fibrin (PRF), Autologous Platelet-rich Fibrin (PRF), Platelet Derived Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Estar Medical dba Medical Technologies, LTDIndustry (pharma, biotech, devices)
- Collaborators
- Global Clinical Research Institute
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. This will help determine the safety and effective use of PRF in the treatment of soft tissue defects.
Detailed description
Chronic wounds are wounds that fail to progress through a normal healing process in a timely fashion. Typically the wounds remain in a pro-inflammatory state. The activation of platelets reacting to tissue damage initiates most healing sequences. The use of activated platelets in the form or platelet-rich plasma (PRP) and/or platelet-rich fibrin (PRF) applied to a clean wound base has been associated with improved wound healing outcomes for bony and soft tissues, especially when associated with standard of care (SOC), including supporting underlying medical conditions, improved perfusion and oxygenation, edema control, removing recurrent insults for trauma, treating infection, and preventing ongoing inflammatory triggers. Activated platelets in the form of Tropocells(R) autologous platelet-rich fibrin (PRF) made from "blood drawn from peripheral veins, and centrifuged into a gel, topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds." Sixteen (16) Subjects will be enrolled to evaluate the efficacy and safety when used to treat chronic noninfected, nonhealing, mild to moderately ischemic wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, Single group
| Arm | Type | Receives |
|---|---|---|
| Participants with non-infected, mild-to-moderate, chronic open soft tissue wound | Active comparator | Device: Platelet-rich fibrin (PRF)Tropocells® Autologous Platelet-Rich Fibrin (PRF) to be topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically debrided wounds", intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Male or female ≥ 18≤ 80 years of age 2. Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ulcer, pressure ulcer, or mechanically or surgically debrided.
- 3. Located in any anatomical location on the body. 4. If more than one non-healing wound is present, an index wound will be selected ≥ 1.0 cm2 size and less than or equal to 25.0 cm2.
- 5. If the wound is in an ulcer cluster the dominant ulcer will be selected, with at least 2.0 cm2 between the index wound and other wounds.
- 6. The study wound will be present for at least thirty (30) days and the subject will have undergone standard of care assessment and intervention, according to the wound type being evaluated, where SOC may include, but not be limited to, proper cleansing and debridement, off-loading, compression, bioburden reduction, moisture management, infection control, optimized perfusion, venous ablation, nutrition supplementation, smoking cessation counseling and medical therapy, and access to wound and underlying disease education and training.
- 7. Neurovascular assessment, conducted according to the assessment typically performed for the wound type will be performed during Screening (Study Visit 1), and repeated at the level normally conducted at the follow-up visits. Perfusion should be adequate to sustain a healing process. Neurological examinations will be performed to document the presence of neuropathy and/or nerve injury.
Key exclusion criteria (19 listed)
- AIDS- acquired immunodeficiency syndrome; COPD-chronic obstructive pulmonary disease; COVID-19- Coronavirus Disease-19; CRP- C-reactive protein; ESR-erythrocyte sedimentation rate; HBV-hepatitis B virus; HCV- hepatitis C virus; HIV- human immune-deficiency virus.
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 |
|---|---|---|
| Platelet-rich fibrin (PRF)Standard of Care will include- 1. Nutritional Supplementation using 14 days Juven(R) 2. Wound Cleansing and Debridement 3. Mild to Moderate Compression as needed for edema Control 4. Off-loading as needed (foot gear, chair cushions, bed mattresses) 5. Antimicrobial Dressings as needed 6. Edema Control 7. Negative Pressure Wound Therapy- as needed 8. Collagen dressings as indicated 9. Optimized perfusion/oxygenation 10. Treated Underlying Medical Conditions | Device | Participants with non-infected, mild-to-moderate, chronic open soft tissue wound |
Primary outcome
Complete Wound Closure
Time frame: From Screening to end of follow-up at 9 weeks
Number of Subjects with Complete Wound Closure- defined as 100% re-epithelialization remaining closed during two (2) consecutive weekly follow-up assessments. * Intent-to-treat analysis * Per-protocol analysis
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 6 Jan 2026.
- Background: PubMed 34357880Bolton L. Platelet-Rich Plasma: Optimal Use in Surgical Wounds. Wounds. 2021 Aug;33(8):219-221.
- Background: PubMed 31134552Milek T, Nagraba L, Mitek T, Wozniak W, Mlosek K, Olszewski W, Ciostek P, Deszczynski J, Kuchar E, Stolarczyk A. Autologous Platelet-Rich Plasma Reduces Healing Time of Chronic Venous Leg Ulcers: A Prospective Observational Study. Adv Exp Med Biol. 2019;1176:109-117. doi: 10.1007/5584_2019_388.
- Background: PubMed 34226023Qu W, Wang Z, Hunt C, Morrow AS, Urtecho M, Amin M, Shah S, Hasan B, Abd-Rabu R, Ashmore Z, Kubrova E, Prokop LJ, Murad MH. The Effectiveness and Safety of Platelet-Rich Plasma for Chronic Wounds: A Systematic Review and Meta-analysis. Mayo Clin Proc. 2021 Sep;96(9):2407-2417. doi: 10.1016/j.mayocp.2021.01.030. Epub 2021 Jul 3.
- Background: PubMed 36556151Meznerics FA, Fehervari P, Dembrovszky F, Kovacs KD, Kemeny LV, Csupor D, Hegyi P, Banvolgyi A. Platelet-Rich Plasma in Chronic Wound Management: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Clin Med. 2022 Dec 19;11(24):7532. doi: 10.3390/jcm11247532.
- Background1. Wounds International: White paper on wound balance - Achieving wound healing with confidence (2023), https://woundsinternational.com/wp-content/uploads/2023/04/HAR23_Supp_Wound-Balance_WINT-Web.pdf.
- Individual participant dataSharing planned: Undecided. Individual Participant Data will be shared with the FDA in support of the IDE, if required. There is no plan to share IPD with journals or publications.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet-rich fibrin (PRF) in people with Wound Chronic Draining and Wound Closure, run by Estar Medical dba Medical Technologies, LTD at 3 sites in United States.
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 11 inclusion and 19 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: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Adrianne P Smith, MD (210-807-2589, p.smithmd@sanogenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Closure (time frame: From Screening to end of follow-up at 9 weeks). 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 NCT07318792, which also lists 5 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 6 Jan 2026.