An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

Burns Clinical Trial

— SIDDX  

Official title:

An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06328010
• Other study ID #: SIDDXAC02
• Status: Enrolling by invitation
• Start date: April 1, 2024
• Est. completion date: June 30, 2030

Study information

• Verified date: June 2024
• Source: Siddhey LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Collect data on various wound treatments and their related wound healing process, in real life settings.

Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments.

Description:

This clinical registry is an observational study to collect prospective and retrospective data on subject 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. Structured data including wound photos are to be collected at the point of care in the subject electronic Case Report Form. The registry will enroll data of 1000-5000 wounds in up to 50 wound care locations. The dataset includes all wound and ulcer types.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: June 30, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Subjects are male or female, 18 years of age or older. At least 50% of the enrolled population must be = 63 years of age.

2. Subjects with one of the following wounds:

1. Diabetic foot ulcer, venous leg ulcers, present for greater than 2-week (documented in medical record) duration if being treated with active SOC.

2. Minor amputation wound sites, post-surgical, or trauma injury

3. Subject has clinical documentation of no visible wound improvement in the wound after 2 weeks of SOC.

4. Study ulcer is a minimum of 0.5 cm2 and a maximum of 50 cm2 at first treatment visit.

5. Subjects' wound score on ISDA tool is:

Grade 1: no infection Grade 2: superficial ulcer with mild infection

6. The subject is able and willing to follow the protocol requirements.

7. The subject has signed informed consent.

8. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of = 30 mmHg; an ABI between 0.7 and = 1.3, or TBI of >6 within 3 months of the first Treatment Visit.

Exclusion Criteria:

1. Subject has a known life expectancy of < 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 history of malignancy within the wound.

4. Known contraindications advance therapy tissues or products.

5. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior.

6. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.

7. Known HbA1C >12%

Related Conditions & MeSH terms

• Burns
• Degloving Injuries
• Diabetic Foot
• Diabetic Foot Ulcer Mixed
• Foot Ulcer
• Leg Ulcer
• Mohs Surgery
• Non-healing Wound
• Trauma Injury
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Wounds and Injuries

Intervention

Biological:
• Advanced Treatment Modalities for wound and injuries
Synthetic, Amniotic, Bovine, Porcine, or other non-human biological grafts or scaffolded grafts
• Standard of care
Standard of care without use of grafts or scaffolded grafts

Other:
• Retrospective wound treatment data collection
Completed wound care treatment regardless of modality.

Locations

Country	Name	City	State
United States	Comprehensive Medicine	Alpine	California
United States	West Hills Hospital and Medical Centers Doctors Suites	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Siddhey LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection of 5000 patients	ONLY Advanced Treatment Therapies VS Rate of Healing	5 year
Secondary	Different types of wounds/injuries heal rate	Segregate data by etiology vs rate of healing	5 years

External Links

•   Advanced Wound Care Market by Product Type (Infection Management, Exudate Management, Active Wound Care, Therapy Devices), Application (Chronic Wounds and Acute Wounds), End User (Hospitals and Community Centers)...
•   Wound care management market overview, 2017, By GlobalData Healthcare