Diabetic Foot UlcerNCT04133493
Omega3 Wound Fish Skin Graft in the Treatment of DFUs
A study testing Kerecis Omega3 Wound and Fibracol in people with Diabetic Foot Ulcer, run by Kerecis Ltd. at 5 sites in United States.
Trial summary
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Kerecis Omega3 Wound and Fibracol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jul 2019to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Presence of a DFU extending at least through the dermis but not into tendon, muscle, or bone, provided it is below the medial aspect of the malleolus (UT grade IA/IC; see Appendix A for definitions).
- The index ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
- Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an ankle brachial index (ABI) between 0.7 and 1.1 within 3 months of SV1, using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle, or a toe brachial index (TBI) of > 0.6 is acceptable.
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- The target ulcer has been offloaded for at least 14 days prior to randomization.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits
Who cannot join
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Index ulcer on the heel
- 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 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
- Subjects who have received a biomedical or topical growth factor for their wound within the previous 30 days.
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- History of radiation at the ulcer site (regardless of time since last radiation treatment).
- Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
- Subject has a known history of poor adherence with medical treatment.
- Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
- Subject is pregnant or breast-feeding.
- Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 within 90 days of randomization.
- Subjects with end stage renal disease as evidenced by a serum creatinine ≥ 3.0 mg/dL within 6 months of randomization.
- Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Christopher Winters, DPM
Carmel, Indiana, 46032
Brock Liden, DPM
Circleville, Ohio, 43113
Eric J. Lullove DPM, PA
Coconut Creek, Florida, 33073
Bert J. Altmanshofer, DPM
Duncansville, Pennsylvania, 16635
Village Podiatry Centers - Smyrna (Allen Raphael, DPM)
Smyrna, Georgia, 30082
About this study
Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Omega3 Wound Fish Skin Graft in the Treatment of Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.
In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound
Read the detailed description
The study is a prospective, multi-center, parallel-group RCT designed to collect outcome data for the treatment of DFUs. The trial will be single blinded in regard to wound healing assessment (confirmation of wound healing will be overseen by an independent wound care adjudicator).
There are two arms in the study, both of which will receive standard of care (SOC): offloading of the DFU (CAM boots (Royce walker with diabetic inlay or equivalent) or total contact casting [TCC] if compliance issues or the subject's foot is too large for a CAM), appropriate sharp or surgical debridement. Patients cannot be on systemic antibiotics prior to randomization, infection management during treatment phase can include systemic antibiotics only in conjunction with debridement.
Arm 1 will receive, in addition, a fish skin graft (KerecisTM Omega3 Wound) secured with Steristrips, sutures or staples, covered with a nonadherent dressing (Adaptic, Systagenix, Yorkshire, UK or equivalent), the product bolstered down to the wound bed with a foam dressing (HydraFoam, DermaRite) and hydrogel as needed to retain adequate moisture balance and padded with stretch gauze and self adherent wrap as needed.
Arm 2 will receive a wound care covering comprising collagen alginate Fibracol plus dressing followed by a padded dressing comprised of 4x4 gauze pads, stretch gauze and self adherent wrap The wound will be dressed by patients or their caregivers at home 3 times a week and by the site investigator 1 day a week.
The study involves two phases: Screening and Treatment
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Kerecis Omega3 Wound, Fibracol
- Keywords
- fish skin graft, omega3 fatty acids
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerecis Omega3 WoundDevice
The intervention group will receive, in addition, a fish skin graft (KerecisTM Omega3 Wound) secured with Steristrips, sutures or staples, covered with a nonadherent dressing (Adaptic, Systagenix, Yorkshire, UK or equivalent), the product bolstered down to the wound bed with a foam dressing (HydraFoam, DermaRite) and hydrogel as needed to retain adequate moisture balance and padded with stretch gauze and self adherent wrap as needed.
The wound will be dressed by the site investigator 1 day a week.
FibracolDevice
The Standard of Care Group will receive Fibracol covered with DSD. Change three times per week
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Placebo comparator | Fibracol Dressing covered with gauze and wrapped with kerlix and wrap. Change 3Xper week Receives: Device: Fibracol |
| Intervention Group | Active comparator | Kerecis affixed with steri-strips, cover with gauze and change one per week . Receives: Device: Kerecis Omega3 Wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
A comparison of the proportion of index ulcers healed at 12 weeks. This is a "Yes/No" assessment The wounds can either be "healed" or "not healed".
Measured: 12 weeks
Secondary outcomes (3)
Time to Heal
Measurement of total time to healing
Measured: 12 weeks
PAR
Percent Area Reducation at 12 weeks
Measured: 12 weeks
Pain reduction: visual analogue scale (VAS)
measured by visual analogue scale (VAS). The subject will be asked to indicate a numerical value that best represents the pain intensity at the index ulcer site on a scale of 0 (minimum value) to 10 (maximum value). The number 0 represents "no pain" the number 5 represents "moderate pain" and the number 10 represents "worst possible pain"
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start31 Jul 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled trial (RCT) with two arms.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric J Lullove, DPM, Principal investigator, Eric J. Lullove DPM, PAGunnar Johannsson, PhD, Study director, Kerecis Ltd.John Lantis, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133493
- Sponsor's protocol ID
- KS-0500
- Status last verified
- Jul 2022
- First submitted
- 8 Oct 2019
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Omega3 Wound Fish Skin Graft in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04133493
- Acronym / sponsor ID
- KS-0500
- Conditions
- Diabetic Foot Ulcer
- Keywords
- fish skin graft, omega3 fatty acids
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.
In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound
Detailed description
The study is a prospective, multi-center, parallel-group RCT designed to collect outcome data for the treatment of DFUs. The trial will be single blinded in regard to wound healing assessment (confirmation of wound healing will be overseen by an independent wound care adjudicator).
There are two arms in the study, both of which will receive standard of care (SOC): offloading of the DFU (CAM boots (Royce walker with diabetic inlay or equivalent) or total contact casting [TCC] if compliance issues or the subject's foot is too large for a CAM), appropriate sharp or surgical debridement. Patients cannot be on systemic antibiotics prior to randomization, infection management during treatment phase can include systemic antibiotics only in conjunction with debridement.
Arm 1 will receive, in addition, a fish skin graft (KerecisTM Omega3 Wound) secured with Steristrips, sutures or staples, covered with a nonadherent dressing (Adaptic, Systagenix, Yorkshire, UK or equivalent), the product bolstered down to the wound bed with a foam dressing (HydraFoam, DermaRite) and hydrogel as needed to retain adequate moisture balance and padded with stretch gauze and self adherent wrap as needed.
Arm 2 will receive a wound care covering comprising collagen alginate Fibracol plus dressing followed by a padded dressing comprised of 4x4 gauze pads, stretch gauze and self adherent wrap The wound will be dressed by patients or their caregivers at home 3 times a week and by the site investigator 1 day a week.
The study involves two phases: Screening and Treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled trial (RCT) with two arms.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Placebo comparator | Device: FibracolFibracol Dressing covered with gauze and wrapped with kerlix and wrap. Change 3Xper week |
| Intervention Group | Active comparator | Device: Kerecis Omega3 WoundKerecis affixed with steri-strips, cover with gauze and change one per week . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old.
- Presence of a DFU extending at least through the dermis but not into tendon, muscle, or bone, provided it is below the medial aspect of the malleolus (UT grade IA/IC; see Appendix A for definitions).
- The index ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
Key exclusion criteria (14 listed)
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Index ulcer on the heel
- 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 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kerecis Omega3 WoundThe intervention group will receive, in addition, a fish skin graft (KerecisTM Omega3 Wound) secured with Steristrips, sutures or staples, covered with a nonadherent dressing (Adaptic, Systagenix, Yorkshire, UK or equivalent), the product bolstered down to the wound bed with a foam dressing (HydraFoam, DermaRite) and hydrogel as needed to retain adequate moisture balance and padded with stretch gauze and self adherent wrap as needed. The wound will be dressed by the site investigator 1 day a week. | Device | Intervention Group |
| FibracolThe Standard of Care Group will receive Fibracol covered with DSD. Change three times per week | Device | Standard of Care Group |
Primary outcome
Wound Healing
Time frame: 12 weeks
A comparison of the proportion of index ulcers healed at 12 weeks. This is a "Yes/No" assessment The wounds can either be "healed" or "not healed".
3 secondary outcomes
Time to Heal
Time frame: 12 weeks
PAR
Time frame: 12 weeks
Pain reduction: visual analogue scale (VAS)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds.Link provided by the sponsor.
- Cost-of-illness studies in chronic ulcers: a systematic review.Link provided by the sponsor.
- Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis.Link provided by the sponsor.
- Predictors of lower-extremity amputation in patients with an infected diabetic foot ulcer.Link provided by the sponsor.
- A Prospective, Postmarket, Compassionate Clinical Evaluation of a Novel Acellular Fish-skin Graft Which Contains Omega-3 Fatty Acids for the Closure of Hard-to-heal Lower Extremity Chronic Ulcers.Link provided by the sponsor.
- Regenerative and Antibacterial Properties of Acellular Fish Skin Grafts and Human Amnion/Chorion Membrane: Implications for Tissue Preservation in Combat Casualty Care.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Lullove, DPM principal investigator
Eric J. Lullove DPM, PA
Gunnar Johannsson, PhD study director
Kerecis Ltd.
John Lantis, MD study chair
Icahn School of Medicine at Mount Sinai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kerecis Omega3 Wound and Fibracol in people with Diabetic Foot Ulcer, run by Kerecis Ltd. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.