Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

Phase 4

Active, not recruiting

• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer

• Registration Number: NCT06562296
• Lead Sponsor: Cellution Biologics

Brief Summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.

Detailed Description

Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SOC) treatment and frequently become infected.

Advanced wound products like CAMPs have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

This study will evaluate the clinical utility of Multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-20
• Study Start: 2024-10-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of ulcers with complete wound closure	1-12 weeks	The percentage of DFU and VLU target ulcers achieving complete wound closure. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.

Secondary Outcome Measures

Name	Time	Method
Percentage of wound area change for target ulcer	1-12 weeks	Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic planimetry and physical examination.
Time to complete closure for ulcer	1-12 weeks	Time to closure will be determined for each treatment group and compared to Standard Of Care. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.
Changes to pain associated with the target ulcer	1-12 weeks	Change in pain in the target ulcer assessed using the Visual Analog Scale (VAS) from week 1 to week 12. VAS is a tool that uses a 0-10 (no to extreme pain) point scale to measure pain intensity.
Incidence of Adverse events	1-12 weeks	The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit.
Determine changes in Quality of Life	1-12 weeks	Changes in quality of life using both the Wound Quality of Life (wQOL) and Forgotten Wound Score (FWS) questionnaires that measure the health-related quality of life (HRQoL) of patients with chronic wounds.; wQOL questionnaire is scored using a 5-point Likert scale, where 0 means "not at all" and 4 means "very much". Higher scores indicate greater impairment of quality of life. Higher the score indicates lower quality of life. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\].; FWS questionnaire measures 12 activities scored 0-4. Responses are summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. Higher the score indicates lower quality of life. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\].

Trial Locations

Locations (4)

Symphony Research; 🇺🇸 Jacksonville, Florida, United States

Sure Step Foot & Ankle; 🇺🇸 Cincinnati, Ohio, United States

RGV Wound Care Group; 🇺🇸 Weslaco, Texas, United States

Family Foot & Ankle; 🇺🇸 Kenosha, Wisconsin, United States