Clinical Registry Collecting Real World Evidence on Wound Care Treatments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2030-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers

NCT04699305

Cutaneous Wounds

RECRUITING

A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

NCT01636362

Burns Wound Healing

COMPLETED NA

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

NCT06921421

Burn Burn Injury

NOT_YET_RECRUITING

Treatment of Pressure Ulcers Using Biological Skin Substitutes

NCT06853210

Pressure Sore

COMPLETED NA

OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

NCT02591537

Wounds

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This clinical registry is an observational study to collect prospective and retrospective data on subjects' health, wounds and wound care procedures from medical centers, including skilled nursing facilities, hospitals, outpatient clinics, Home Health and any other medical environment where wounds are treated.

The registry will enroll data of up to 5000 subjects in up to 100 wound care locations. The dataset includes all wound and ulcer types. Investigators will follow Institutional standards for routine wound care practices. The study products supplied through this study will be applied to the wounds as an adjunct to the standard of care treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wounds and Injuries Burns Mohs Surgery Diabetic Foot Ulcer Mixed Venous Leg Ulcer Non-healing Wound Trauma Injury Injury and Wounds Degloving Injuries Pressure Ulcers, Bedsores, Decubitus Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wound Treatment

Interventions are at the discretion of treating clinicians and include standard and advanced wound therapies.

Various types of wound care treatments

Intervention Type COMBINATION_PRODUCT

Treatments including, but not limited to:

* Hydrocolloid
* Foam
* Alginate
* Hydrogel
* Collagen
* Antimicrobial (e.g., silver, iodine)
* Film
* Composite
* Negative Pressure (NPWT)
* Amniotic-based

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Various types of wound care treatments

Treatments including, but not limited to:

* Hydrocolloid
* Foam
* Alginate
* Hydrogel
* Collagen
* Antimicrobial (e.g., silver, iodine)
* Film
* Composite
* Negative Pressure (NPWT)
* Amniotic-based

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is male or female ≥18 years of age.
2. Subject has an ulcer (Diabetic foot ulcer, Venous stasis ulcer, etc.), injury (trauma, post -surgical, MOHS treatment), Burns injury, and/or other acute/chronic wounds.
3. Subject has clinical documentation of no visible wound improvement in the wound after 4 weeks of standard of care therapy.
4. Study wound is a minimum of 1 cm2 at Visit 1.
5. The subject is able and willing to follow the protocol requirements.
6. The subject has signed the informed consent form.
7. Subject has adequate circulation to the affected extremity. Note: This will be confirmed by vascular perfusion assessment performed prior to enrollment, if clinically indicated per Institutional standard of care.

Exclusion Criteria

1. Subject has a known life expectancy \< 1 year.
2. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver, or pulmonary disease, lupus, palliative care or sickle cell anemia.
3. Subject currently being treated for an active malignant disease or subjects with a history of malignancy within the wound.
4. Known contraindications to advance therapy tissues or products.
5. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10 mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the wound surface within one month prior to Visit 1.
6. Affected extremity requiring hyperbaric oxygen during the study or within 2 weeks of Visit 1.
7. Known HbA1c \>12%.
8. Subjects who are pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No