Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
NCT Number: NCT06562296
Acronym: CAMPLIFE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Diabetic Foot Ulcer|Venous Leg Ulcer
Interventions: OTHER: Amnion-Intermediate-Chorion|OTHER: Amnion-Chorion-Amnion|PROCEDURE: Standard of Care
Sponsor: Cellution Biologics
Collaborators: SerenaGroup, Inc.|LifeCell
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 292
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-07-25

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.

Primary Outcome Measures: Percentage of ulcers with complete wound closure, 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., 1-12 weeks
Secondary Outcome Measures: Time to complete closure for ulcer, 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., 1-12 weeks|Percentage of wound area change for target ulcer, Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic planimetry and physical examination., 1-12 weeks|Incidence of Adverse events, The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit., 1-12 weeks|Changes to pain associated with the target ulcer, 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., 1-12 weeks|Determine changes in Quality of Life, 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. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\]., 1-12 weeks
Other Outcome Measures: Changing in bacterial load, Changes in chronic inhibitory bacterial load (CIBL) measured using fluorescence imaging \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\]., 1-12 weeks|Changes in ambulation, Changes in functional ambulation based on Functional Ambulatory

Category Scale (FACS) - VLU subjects only. The FACS is a 6-point (0-5) functional walking test that evaluates ambulation ability. Scoring:

0 indicates that the patient is a non-functional ambulator (cannot walk)

1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3)

4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score), 1-12 weeks