Diabetic FootNCT05198544
Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)
A study testing Hēlaquis Matrix is a hyaluronic acid matrix (HaM) in people with Diabetic Foot, run by SerenaGroup, Inc..
Trial summary
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Hēlaquis Matrix is a hyaluronic acid matrix (HaM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Presence of a diabetic foot ulcer, Wagner 1 or 2 grade, extending at least through the dermis. The ulcer may extend down to subcutaneous tissue, tendon, or muscle.
- The ulcer must be below the medial aspect of the malleoli.
- The index ulcer will be the largest ulcer if 2 or more ulcers are present on the same extremity. If other ulcerations are present on the same foot, they must be more than 2 cm from the index ulcer.
- Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit.
- Study ulcer size is a minimum of 0.75 cm2 and a maximum of 5 cm2 at first treatment visit.
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- Adequate circulation to the affected extremity as demonstrated by a transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg, OR an Ankle Brachial Index (ABI - measure of blood flow to the ankle) between 0.7 and 1.3 OR Toe Brachial Index greater than 0.5 within 3 months of the first Screening Visit.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject has read and signed the IRB approved Informed Consent Form before screening procedures are undertaken.
Who cannot join
- Study 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.
- 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 one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- History of radiation at the ulcer site.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
- Known Osteomyelitis or bone infection of the affected foot or leg as verified by diagnostic imaging within 30 days prior to enrollment.
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- Subject is pregnant or breast feeding.
- Study ulcer with a history of treatment with hyperbaric oxygen or a cellular or Tissue-based Product (CTP) within 30 days of enrollment.
- Subject has a known or suspected allergy to the test material.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Prospective Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs.
After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.
Read the detailed description
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs.
After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.
The Screening Phase consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria, treatment.
At the Screening Visit (SV), written informed consent is obtained from the subject by the Investigator or designee prior to the performance of any other protocol-specific procedure.
At the SV, the Investigator will select the Index (study) ulcer. Each subject will have only one DFU selected as the Index (study) ulcer. If the subject has more than one ulcer at the SV, the Investigator will select the largest ulcer that meets the eligibility criteria of the protocol as the Index (study) ulcer.
The SV is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. Those subjects who meet the eligibility criteria may transition to Treatment Visit 1 (TV1) on the same day as the SV or at a later date.
The Treatment Phase (12 Weeks) Subjects who meet eligibility criteria at the SV will receive HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects may receive up to eight applications of HaM. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks. Subjects whose ulcers do not achieve closure at or by 12 weeks or who experience an amputation will be deemed treatment failures.
- Conditions
- Diabetic Foot
- Being tested
- Hēlaquis Matrix is a hyaluronic acid matrix (HaM)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hēlaquis Matrix is a hyaluronic acid matrix (HaM)Device
Hēlaquis Matrix is a hyaluronic acid matrix (HaM) derived from the American Alligator and indicated for the treatment of chronic wounds. Hyaluronic Acid (HA) is a naturally occurring non sulphated glycosaminoglycan consisting of a linear sequence of D-glucuronic and N -acetyl-Dglucosamine. It is present in connective tissue and plays a role in several biological processes including tissue repair.
| Study group | Role | What they receive |
|---|---|---|
| Hēlaquis Matrix is a hyaluronic acid matrix (HaM) | Experimental | Subjects will receive weekly application of Ham along with standard of care therapy for eight (8) weeks unless healing occurs prior to 8 weeks. Receives: Device: Hēlaquis Matrix is a hyaluronic acid matrix (HaM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Wound healing in Wagner 1 and 2 grade DFUs by wound size
To evaluate the effectiveness of HaM as an adjunctive treatment in facilitating complete wound healing in Wagner 1 and 2 grade DFUs when compared to well-established standard of care healing rates
Measured: 12 weeks
Secondary outcomes (3)
Evaluate Wound healing by wound closure
Proportion of wounds healed at 12 weeks
Measured: 12 weeks
Evaluate wound healing by surface area reduction of greater than 40%
Proportion of wounds with surface area reduction of greater than 40% at 4 weeks
Measured: 4 weeks
Occurrence of adverse events through case report forms
Incidence of adverse events
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 posted20 Jan 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period. The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Lacerta Life Sciences, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198544
- Sponsor's protocol ID
- LACERTA-001
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)
- ClinicalTrials.gov ID
- NCT05198544
- Acronym / sponsor ID
- LACERTA-001
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Lacerta Life Sciences, LLC
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2022 (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.
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs.
After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.
Detailed description
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs.
After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.
The Screening Phase consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria, treatment.
At the Screening Visit (SV), written informed consent is obtained from the subject by the Investigator or designee prior to the performance of any other protocol-specific procedure.
At the SV, the Investigator will select the Index (study) ulcer. Each subject will have only one DFU selected as the Index (study) ulcer. If the subject has more than one ulcer at the SV, the Investigator will select the largest ulcer that meets the eligibility criteria of the protocol as the Index (study) ulcer.
The SV is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. Those subjects who meet the eligibility criteria may transition to Treatment Visit 1 (TV1) on the same day as the SV or at a later date.
The Treatment Phase (12 Weeks) Subjects who meet eligibility criteria at the SV will receive HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period.
During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects may receive up to eight applications of HaM. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks. Subjects whose ulcers do not achieve closure at or by 12 weeks or who experience an amputation will be deemed treatment failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for the remainder of the 12-week trial period. The standard of care in this study consists of offloading of the DFU using a total contact cast or fixed ankle walker, sharp debridement, infection management with the use of antiseptics and proper moisture balance.
| Arm | Type | Receives |
|---|---|---|
| Hēlaquis Matrix is a hyaluronic acid matrix (HaM) | Experimental | Device: Hēlaquis Matrix is a hyaluronic acid matrix (HaM)Subjects will receive weekly application of Ham along with standard of care therapy for eight (8) weeks unless healing occurs prior to 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years old.
- Presence of a diabetic foot ulcer, Wagner 1 or 2 grade, extending at least through the dermis. The ulcer may extend down to subcutaneous tissue, tendon, or muscle.
- The ulcer must be below the medial aspect of the malleoli.
- The index ulcer will be the largest ulcer if 2 or more ulcers are present on the same extremity. If other ulcerations are present on the same foot, they must be more than 2 cm from the index ulcer.
- Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit.
Key exclusion criteria (9 listed)
- Study 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.
- 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 one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- History of radiation at the ulcer site.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
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 |
|---|---|---|
| Hēlaquis Matrix is a hyaluronic acid matrix (HaM)Hēlaquis Matrix is a hyaluronic acid matrix (HaM) derived from the American Alligator and indicated for the treatment of chronic wounds. Hyaluronic Acid (HA) is a naturally occurring non sulphated glycosaminoglycan consisting of a linear sequence of D-glucuronic and N -acetyl-Dglucosamine. It is present in connective tissue and plays a role in several biological processes including tissue repair. | Device | Hēlaquis Matrix is a hyaluronic acid matrix (HaM) |
Primary outcome
Evaluate Wound healing in Wagner 1 and 2 grade DFUs by wound size
Time frame: 12 weeks
To evaluate the effectiveness of HaM as an adjunctive treatment in facilitating complete wound healing in Wagner 1 and 2 grade DFUs when compared to well-established standard of care healing rates
3 secondary outcomes
Evaluate Wound healing by wound closure
Time frame: 12 weeks
Evaluate wound healing by surface area reduction of greater than 40%
Time frame: 4 weeks
Occurrence of adverse events through case report forms
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Hēlaquis Matrix is a hyaluronic acid matrix (HaM) in people with Diabetic Foot, run by SerenaGroup, Inc..
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Serena, MD, FACS (814-688-4000, serena@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Wound healing in Wagner 1 and 2 grade DFUs by wound size (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 26 Apr 2023.