An interventional study of Zorflex Activated Carbon Dressing and Standard of Care in Wound Infection, sponsored by Brock Liden, DPM. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Brock Liden, DPM · Not applicable, Interventional, and Treatment
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Among 85 studies in Wound Infection with a site in United States — 8 open to participants now, 9 under way, 2 of them phase 3. Wound Infection · United States.
Among the 85 studies in Wound Infection with a site in United States, this one is the 62nd largest by enrollment of the 78 interventional ones that give a count, is one of 3 that started in 2017, is one of 35 with no phase, and was the 58th registered.
270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.
Browse Wound Infection studies →8 of the 85 studies in Wound Infection with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Major Extremity Trauma Research Consortium · Sites in United States
Ages 18+
University of Pittsburgh · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Major Extremity Trauma Research Consortium · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Wound Infection studies recruiting now, 17 (74%) set no upper age limit and 1 (4%) stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 13 · Phase 3 11 · Phase 4 13
First in 1994; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 141 across 228 interventional studies indexed under Wound Infection.
Median enrollment 123 across the 78 interventional studies, 62 across the 6 observational. Of the 65 that completed or were terminated, 33 (51%) have results posted.
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17 of 85 have an industry lead sponsor. The 10 most frequent:
Brock Liden, DPM is the lead sponsor of 2 studies on the registry; none are open to participants now.
Brock Liden, DPM has 1 study filed under Wound Infection — fewer than ten, so there is no comparison to draw.
5 of the studies in Wound Infection with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05699174Phase 3Major Extremity Trauma Research ConsortiumPO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation | 2027-09 |
| NCT07391735Brigham and Women's HospitalPost-Surgery Wound Healing Tracking With MyHealthPal App | 2027-01-01 |
| NCT06189638Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers | 2027-04-30 |
| NCT07004764Johns Hopkins UniversityEnhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging. | 2027-09 |
| NCT06218355University of Texas Southwestern Medical CenterIMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine | 2027-09-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 85 studies in Wound Infection with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this randomized, prospective study is to evaluate how this activated carbon dressing affects the total bacterial load and biofilm in a wound bed in wounds of the lower extremity and foot. We anticipate that the use of Zorflex® Activated Carbon Cloth dressing will maintain the bacterial burden in the wound bed below the level of critical colonization, with potential secondary benefits of pain reduction, decrease in inflammation, and control of odor. Wound bed healing progression/acceleration also will be assessed.
Wounds located on the lower extremity and feet are caused by several conditions, including diabetes and venous insufficiency. These types of wounds may not heal quickly and can become chronic. Chronic wounds are at risk for infection and limb amputation. As such, these wounds are a serious health issue, especially in diabetics and the elderly, and pose a significant public health burden. The healing of such wounds is an ongoing challenge to clinicians, who continue to seek effective management modalities.
The study treatment evaluated in this study is Zorflex® dressing (Chemviron Carbon Cloth Carbon, West Midlands, United Kingdom; a division of Calgon Carbon Corporation, Pittsburgh, PA). According to the Instructions for Use for the product, it is a low-adherent, 100% pure activated carbon cloth dressing that highly conforms to the body contours and maintains contact with the wound surface. It provides an effective antimicrobial barrier for a minimum of 7 days per dressing, protecting the wound from invasive microorganisms, while exhibiting an antimicrobial effect against microorganisms already present in the wound. The dressing may be used either dry or moistened with sterilized water. Zorflex® is indicated as an antimicrobial dressing over dry or discharing, partial and full thickness wounds.
The following unique properties of the activated carbon dressing are believed to aid in wound healing and patient comfort when used for wound management: 1) antimicrobial; 2) odor management; and 3) conductive. The dressing is antimicrobial and manages odor because of its naturally occurring "van der Waal's" electrostatic forces. These forces draw small gas or liquid molecules, including endotoxins and odor molecules, away from the wound into the highly structured micropores of the dressing, where they become trapped. Bacteria cells also are attracted to the dressing, but are too big to enter the micropores. Instead, the microorganisms become trapped on the surface, away from the wound bed. Electrostatic tension builds up in the trapped microorganisms until the tension overcomes the tensile strength of the cell walls, at which time the cell walls of the microorganisms rupture, killing the microorganisms. Any endotoxins released in the process are drawn into the micropores and also become trapped. The conductive nature of the dressing restores the body's natural transepithelial potential across the wound bed, thereby aiding in healing. The positive effects of electrostimulation on wound healing have been previously established.
Several studies, primarily case series, have reported promising preliminary results with the use of Zorflex® as an antimicrobial dressing for wound management. In a case series involving four patients with recalcitrant venous leg ulcers that were prone to recurrent infection, treatment with this particular activated carbon cloth dressing resulted in a reduction in clinical signs of infection, such as exudate and pain levels, and improvement in wound bed appearance after 7 days. A retrospective study evaluating the use of this activated carbon cloth dressing for the management of 18 chronic wounds demonstrated 90.7% wound closure at 5 weeks. Finally, another case series examining the use of Zorflex® in chronic lower extremity and foot wounds demonstrated a reduction in odor control and progression of healing with the use of the dressing.
Studies examining the efficacy of such activated carbon dressings are limited and, therefore, more research, particularly randomized and prospective in design, is needed to better elucidate possible effects of this dressing on preventing infection and promoting healing. The purpose of this multi-center, randomized, prospective study is to evaluate how this activated carbon dressing affects the total bacterial load and biofilm in a wound bed in wounds of the lower extremity and foot. We anticipate that the use of Zorflex® Activated Carbon Cloth dressing will maintain the bacterial burden in the wound bed below the level of critical colonization, with potential secondary benefits of pain reduction, decrease in inflammation, and control of odor. Wound bed healing progression/acceleration also will be assessed.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized into the experimental group will only be treated using an activated carbon dressing (Zorflex® Activated Carbon Cloth Dressing; Chemviron Carbon Cloth Carbon, West Midlands, United Kingdom; a division of Calgon Carbon Corporation, Pittsburgh, PA) for wet wounds or with saline and Zorflex® Activated Carbon Cloth Dressing for dry wounds.
Device: Zorflex Activated Carbon Dressing
Patients with wet wounds randomized into the control group will be treated using foam, calcium alginate or compressive dressings, whereas those with dry wounds will be treated with hydrogel and compressive dressings.
Device: Standard of Care
Antimicrobial dressing
foam, calcium alginate, hydrogel, or compressive dressings
Total Bacterial Load
Total bacterial load will be measured total colony forming units (CFUs) as determined from laboratory findings
Time frame: 4 weeks
Pain Associated with Wound
Patients will rate their pain on a Visual Analog Scale (VAS) that consists of a 10cm (100mm) line with the descriptor "no pain" positioned at the left pole and the descriptor "worst pain imaginable" positioned at the right pole.
Time frame: 4 weeks
Wound Bed Inflammation
Protease laboratory measurements of the wound bed will be use to elevate wound bed inflammation.
Time frame: 4 weeks
Wound Odor
Wound odor will be assessed by both the patient and investigator using Visual Analog Scale (VAS) that consists of a 10cm (100mm) line with the descriptor "no odor" positioned at the left pole and the descriptor "extremely offensive odor" positioned at the right pole.
Time frame: 4 weeks
Wound Size Progression
Wound size measurements obtained from the software utilized by the eKare inSight™ (eKare, Inc., Fairfax, VA) system will be used to determine wound bed healing progression.
Time frame: 4 weeks
Plan to share: No — No plan to make individual participant data available to other researchers.
Ran from Jun 2017 to primary completion in Aug 2018, 13 months.
Of 59 non-industry interventional studies with no phase under Wound Infection, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 53. This study's 13 months is below that.
Counting every sponsor, half of 64 studies reached it within 19 months; a quarter within 13 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Brock Liden, DPM