Profound Matrix for Chronic Wounds

Recruiting at 4 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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.

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.

How is the Profound Matrix treatment different from other treatments for chronic wounds?

The Profound Matrix treatment is unique because it combines multiple applicators, such as the Matrix Pro, Sublime, and Sublative RF, which may offer a novel approach to treating chronic wounds by potentially enhancing the wound healing environment and reactivating the healing process, unlike traditional wound care products. ^{1 2 3 4 5}

Research Team

Konika Schallen, MD

Principal Investigator

Candela Institue for Exellence

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. [2022]

2. Germany 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. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Use of a flowable wound matrix to treat lower limb vascular ulcers. [2022]

5. United States 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. [2020]