Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
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|ClinicalTrials.gov Identifier: NCT06035523|
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 15, 2023
|Condition or disease||Intervention/treatment||Phase|
|Wound Healing Diabetic Foot Chronic Foot Ulcer Foot Ulcer||Device: Endoform™ Antibacterial Device: Endoform™ Natural Device: Symphony™||Not Applicable|
About 50 subjects will take part in this study. The purpose of this study is to evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ (together, the 'Products') in the treatment of acute or chronic non-healing wounds, including diabetic foot ulcers Wagner Grade 1 or 2, after 12 weeks of treatment.
Following initial enrollment, eligible subjects will then undergo
- a treatment phase involving weekly treatment and evaluations for up to 12 weeks,
- subjects that heal will enter a follow-up period that includes 1 visit (Healing Confirmation Visit), 2 weeks from initial healing.
- If the subject does not heal, they will exit at Week 13, End of Study visit.
All subjects will require accepted routine procedures as part of standard of care (SOC): offloading of the DFU (removeable cast boot or total contact casting [TCC] if the subject's foot is too large for a removeable cast boot), appropriate sharp debridement, and infection management. In addition, each subject will receive a wound care covering comprising of either Endoform™ Antimicrobial, Endoform™ Natural or Symphony™ followed by a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Pilot Study Evaluating Wound Closure With a Unique Staged Application of Endoform™ and Symphony™ in the Treatment of Non-Healing Diabetic Foot Ulcers|
|Actual Study Start Date :||December 29, 2021|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||June 30, 2024|
Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading
Device: Endoform™ Antibacterial
Application of Endoform™ Antibacterial
Device: Endoform™ Natural
Application of Endoform™ Natural
Application of Symphony™
- Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks [ Time Frame: 12 weeks ]Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
- Time to heal within 12 weeks [ Time Frame: 12 weeks ]Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
- Percentage area reduction at 12 weeks [ Time Frame: 12 weeks ]Area reduction percentage of ulcers at 12 weeks
- Changes in wound quality of life (per W-QoL) [ Time Frame: 12 weeks ]Changes in wound quality of life (W-QoL), using the W-QoL short questionnaire administered on Study Visit 1 (as a baseline) and after 12 weeks of treatment (End of Study Visit). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
- Change in subjects reported pain levels (NPRS) [ Time Frame: 12 weeks ]Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at baseline (Study Visit 1) and after 12 weeks of treatment EOS visit (End of Study Visit).On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".
- Product wastage [ Time Frame: 12 weeks ]
For each product, the size actually used will be the basis to calculate the area of the product.
Based on the investigator's notes, wound area at time of application will be calculated as a rectangle (length x width) reduced to an ellipsoid.
Wastage = ((area of product - area of wound)/area of product)*100
- Cost to closure [ Time Frame: 12 weeks ]Calculation of cost of treatment, including number of device applications for each treatment group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035523
|Contact: Shelby Caylorfirstname.lastname@example.org|
|Contact: Frances Parker, DMPemail@example.com|
|United States, Florida|
|South Florida Lower Extremity Center||Recruiting|
|Hollywood, Florida, United States, 33312|
|Contact: Karla Taylor 954-278-3890 ext 3 firstname.lastname@example.org|
|Principal Investigator: Nooshin Zolfaghari, DPM|
|United States, Virginia|
|Foot and Ankle Specialists of the Mid-Atlantic||Recruiting|
|Salem, Virginia, United States, 24153|
|Contact: Kristie Guilliams 540-395-3107 email@example.com|
|Principal Investigator: Ivan Rubiano, DPM|
|Study Chair:||David Armstrong, DPM, MD PhD||Keck School of Medicine|