Profound Matrix for Chronic Wounds

Not currently recruiting at 5 trial locations

Overseen By Katherine L Coleman, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Candela Corporation

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, Cancer, Cardiac disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the Profound Matrix system in treating chronic wounds. Participants will receive treatments using one or more applicators from the Profound Matrix system, which may include Sublime, Sublative RF, and/or Matrix Pro. The study seeks healthy individuals with skin types ranging from very fair to dark (Fitzpatrick Skin Type I - VI) who are open to receiving these treatments and willing to have their progress documented. As an unphased trial, participants contribute to innovative research that may lead to new treatment options for chronic wounds.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using immunosuppressive medications or have had systemic corticosteroid therapy in the past six months, you may not be eligible to participate.

What prior data suggests that the Profound Matrix system is safe for treating chronic wounds?

Research has shown that the Profound Matrix system, including the Matrix Pro applicator, has received FDA approval for use in the United States, meeting specific safety standards for its intended use.

Previous studies have examined the safety of the Profound Matrix system and its Sublime and RF applicators, focusing on the system's safety and effectiveness. Although specific side effects are not listed, the approval suggests no major safety issues.

Overall, this approval and past studies support the treatment's safety, indicating it is likely safe for its approved uses. However, consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Profound Matrix is unique because it utilizes a combination of advanced applicators—Sublime, Sublative RF, and Matrix Pro—to treat chronic wounds. Unlike traditional treatments that often involve topical applications or surgical interventions, Profound Matrix harnesses radiofrequency technology to stimulate the skin’s natural healing processes. Researchers are excited about this approach because it has the potential to accelerate wound healing by enhancing collagen production and improving skin texture, offering a novel, non-invasive alternative to conventional methods.

What evidence suggests that the Profound Matrix system is effective for chronic wounds?

Research suggests that the Profound Matrix system could help treat chronic wounds. In this trial, participants may receive treatment with any of the Profound Matrix applicators, including the Matrix Pro applicator, which previous studies have shown to be safe and effective. Tests indicate that this system can accelerate wound healing. The Matrix Pro applicator aims to reduce discomfort and recovery time, making it an appealing option for patients. Overall, these findings support its potential benefits in wound care. ^{1 2 3 5 6}

Who Is on the Research Team?

Konika Schallen, MD

Principal Investigator

Candela Institue for Exellence

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-75 with any skin type who want to improve loose skin or wrinkles. Participants must be willing to undergo Profound Matrix treatments, follow the study schedule, and allow their photos to be used. Exclusions include pregnancy, certain implants, active cancer treatment within a year, severe conditions like heart disorders or immune suppression, untreated herpes in the area, poor wound healing history, recent aesthetic procedures in the area.

Inclusion Criteria

Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials (Subject identity will be masked)

I am willing to undergo Profound Matrix treatments.

Willing to provide signed, informed consent to participate in the study

Exclusion Criteria

I do not have severe heart problems.

Permanent synthetic fillers (e.g. silicone) in the treatment area

In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive treatments with the Profound Matrix system using various applicators for up to 16 weeks

16 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including subject satisfaction and aesthetic improvement assessments

16 weeks

2 visits (in-person)

Long-term follow-up

Participants may be monitored for long-term safety and effectiveness, contributing to research and development

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Profound Matrix

Trial Overview The Profound Matrix system is being tested for its safety and effectiveness on improving skin appearance. This non-randomized trial will use different applicators (Sublime/Sublative RF/Matrix Pro) across multiple centers without comparing it to other treatments.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Study subjects may be treated with any of the Profound Matrix applicators: Sublime, Sublative RF and/or Matrix Pro. Treatments may include combination of applicators or additional commercial devices per PI discretion.

Profound Matrix is already approved in United States, European Union for the following indications:

Approved in United States as Profound Matrix System for:

• Facial wrinkles
• Acne scars
• Striae
• Electrocoagulation and hemostasis

Approved in European Union as Profound Matrix System for:

• Wrinkles
• Acne scars
• Striae
• Electrocoagulation and hemostasis

Who Is Running the Clinical Trial?

Candela Corporation

Lead Sponsor

Trials

22

Recruited

2,200+

Published Research Related to This Trial

In a study involving 73 patients with diabetic foot ulcers, treatment with OASIS Wound Matrix resulted in a higher healing rate (49%) compared to Regranex Gel (28%) after 12 weeks, suggesting its potential effectiveness.

While the difference in healing rates was not statistically significant (P = .055), the results indicate that OASIS Wound Matrix is at least as effective as Regranex for treating full-thickness diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Niezgoda, JA., Van Gils, CC., Frykberg, RG., et al.[2022]

In a study of 22 patients with hard-to-heal vascular leg ulcers, the advanced flowable wound matrix (FWM) treatment was well tolerated and resulted in a high healing rate, with 85% of ulcers healing within 12 weeks.

FWM treatment also significantly reduced the need for amputations compared to standard wound care, indicating its effectiveness in managing complex wound cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a flowable wound matrix to treat lower limb vascular ulcers. Florio, A., Sallustro, M.[2022]

In a 16-week study involving 168 patients, the human acellular dermal matrix DermACELL showed a significantly higher healing rate for diabetic foot ulcers compared to conventional care (67.9% vs 48.1%).

DermACELL also demonstrated a greater average reduction in wound area compared to both conventional care and another acellular dermal matrix, Graftjacket, indicating its potential as an effective treatment option for these ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Walters, J., Cazzell, S., Pham, H., et al.[2020]

In a study involving 19 patients with difficult-to-heal wounds, the ovine forestomach matrix (OFM) treatment led to a 50% closure rate of wounds after 12 weeks.

The average reduction in wound surface area was 73.4%, indicating that OFM could be a promising option for treating recalcitrant wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes following the use of ovine forestomach matrix (endoform dermal template) to treat chronic wounds. Liden, BA., May, BC.[2022]

In a study of 314 patients with chronic wounds that had not responded to previous treatments, Tegaderm™ Matrix was effective in reducing wound size by at least 50% in 72.9% of cases, demonstrating its efficacy in promoting healing.

The treatment was well tolerated, with only 4.7% of patients reporting minor adverse events, indicating a favorable safety profile for this wound dressing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-interventional study to investigate the efficacy and safety of Tegaderm™ Matrix in the treatment of patients with therapy-refractory chronic wounds. Weindorf, M., Körber, A., Klode, J., et al.[2012]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06157567

NCT06157567 | Clinical Feasibility Study to Evaluate the ... The clinical study is to evaluate the safety and performance of the Profound Matrix system with Sublime applicator, RF applicator and Matrix Pro applicator for ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06192550

Functional Usability and Feasibility Testing of the Profound ... This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for ...

3. withpower.com withpower.com/trial/phase-cutis-laxa-4-2022-ee1b4

Profound Matrix for Chronic Wounds · Info for Participants In a study involving 73 patients with diabetic foot ulcers, treatment with OASIS Wound Matrix resulted in a higher healing rate (49%) compared to Regranex Gel ( ...

4. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/efficacy-and-safety-of-matrix-pro/

Efficacy and Safety of Matrix Pro The PFX22003 clinical study is to evaluate the efficacy and safety looking into treatment with the Matrix Pro Applicator on the Profound Matrix delivery system.

5. dermatologytimes.com dermatologytimes.com/view/fda-clears-candela-s-matrix-radiofrequency-platform-for-treatment-of-facial-wrinkles

FDA Clears Candela's Matrix Radiofrequency Platform for ... "The advanced technology of the Matrix Pro applicator ensures minimal discomfort and downtime, making it a preferred choice for patients seeking ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06157567/clinical-feasibility-study-to-evaluate-the-safety-and-performance-of-the-profound-matrix-system

Clinical Feasibility Study to Evaluate the Safety and ... The clinical study is to evaluate the safety and performance of the Profound Matrix system with Sublime applicator, RF applicator and Matrix Pro ...