Diabetic Foot UlcersPhase 2ABSOLVENCT03037970
Evaluation of ABSOLVE in Diabetic Foot Ulcers
A Phase 2 study testing RhPDGF-BB in people with Diabetic Foot Ulcers, run by Lynch Biologics LLC at 1 site in Guatemala.
Trial summary
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- RhPDGF-BB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGuatemala
- Study dates
- 30 Jan 2017to 15 Oct 2017
- Phase
- Phase 2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 30 to 75 years of age
- A diagnosis of Type 1 or 2 diabetes with HbAlc between 6 and 12%, an adequate blood supply defined as TcpO2 > 30 mmHg or an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
- A DFU 2 cm2-14 cm2 that extends into the subcutaneous tissues or beyond (≤Wagner Grade 2)
- A DFU of at least 6 weeks duration and under care of the study investigator for at least 2 weeks following standard wound debridement with less than 30% healing
- Body Mass Index (BMI) of 18.5 to 40 kg/m2
- Co-morbidities are under control and non-life threatening as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests
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- A negative pregnancy test at Screening
- Both males and WCBP agree to use acceptable contraceptive methods while on study
- Able to comprehend and sign an ICF.
Who cannot join
- Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with interpretation of safety data
- Current or recent history of significant bacterial, fungal, viral, or mycobacterial infection
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- History of myocardial infarction, congestive heart failure, or stroke
- History of psychotic disorder
- History of alcoholism or drug addiction
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- Positive drug screen at Screening
- Current treatment or treatment within 30 days prior to first dose of study products with another investigational drug or current enrollment in another clinical trial
- Known history of HIV, hepatitis B, or hepatitis C
- Known hypersensitivity to any of the product's components
- Subjects who are unable or unlikely to comply with the protocol
- Pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
Guatemala1 site, 1 recruiting
- Recruiting
Centro Medico Militar
Guatemala City, 010116
About this study
Official title: A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).
Read the detailed description
Patients with diabetes are at risk for developing serious health problems that may affect the feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the lives of millions of diabetic patients, representing one of the most common and serious complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer (DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%. More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5 will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States each year occurs secondary to complications of diabetes mellitus. After a major amputation, 50% of patients will have another limb amputated within two years. Mortality rates subsequent to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years. Patients with a history of a DFU have a 40% greater mortality rate compared to patients with diabetes alone. Improved treatments for DFUs are clearly a matter of great significance.
In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in treating diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- RhPDGF-BB, Placebo
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhPDGF-BBDrug
Also called ABSOLVE
One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.
PlaceboOther
Collagen Wound Dressing wetted with buffer.
| Study group | Role | What they receive |
|---|---|---|
| ABSOLVE | Experimental | Type I collagen sheet soaked in a solution containing rhPDGF-BB. Receives: Drug: RhPDGF-BB |
| Placebo | Placebo comparator | Collagen sheet soaked with saline solution. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.
Measured: Week 0 - 24
Successful wound healing for at least two consecutive measurements. (Efficacy)
Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.
Measured: Week 12
Secondary outcomes (3)
Wound Size
The percent change in wound size (closure) over time.
Measured: Week 0 - 24
Wound Closure
Percent incidence of complete wound closure over time.
Measured: Week 0 - 24
Complication rate
Reduction in complications.
Measured: Week 0 - 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start30 Jan 2017 (estimated)
- Primary completion15 Aug 2017 (estimated)
- Study completion15 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, blinded, two-arm, clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lynch Biologics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medelis Inc., Centro Medico Militar
- Responsible party
- Sponsor
- Investigators
- Luis Gonzalez, MD, Principal investigator, Centro Medico Militar, Guatemala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037970
- Sponsor's protocol ID
- Lynch 02-01
- Acronym
- ABSOLVE
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03037970
- Acronym / sponsor ID
- ABSOLVE / Lynch 02-01
- Conditions
- Diabetic Foot Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lynch Biologics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medelis Inc., Centro Medico Militar
- Study start
- 30 Jan 2017 (estimated)
- Primary completion
- 15 Aug 2017 (estimated)
- Study completion
- 15 Oct 2017 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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.
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).
Detailed description
Patients with diabetes are at risk for developing serious health problems that may affect the feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the lives of millions of diabetic patients, representing one of the most common and serious complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer (DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%. More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5 will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States each year occurs secondary to complications of diabetes mellitus. After a major amputation, 50% of patients will have another limb amputated within two years. Mortality rates subsequent to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years. Patients with a history of a DFU have a 40% greater mortality rate compared to patients with diabetes alone. Improved treatments for DFUs are clearly a matter of great significance.
In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in treating diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, blinded, two-arm, clinical study
| Arm | Type | Receives |
|---|---|---|
| ABSOLVE | Experimental | Drug: RhPDGF-BBType I collagen sheet soaked in a solution containing rhPDGF-BB. |
| Placebo | Placebo comparator | Other: PlaceboCollagen sheet soaked with saline solution. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 30 to 75 years of age
- A diagnosis of Type 1 or 2 diabetes with HbAlc between 6 and 12%, an adequate blood supply defined as TcpO2 > 30 mmHg or an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
- A DFU 2 cm2-14 cm2 that extends into the subcutaneous tissues or beyond (≤Wagner Grade 2)
- A DFU of at least 6 weeks duration and under care of the study investigator for at least 2 weeks following standard wound debridement with less than 30% healing
- Body Mass Index (BMI) of 18.5 to 40 kg/m2
Key exclusion criteria (12 listed)
- Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with interpretation of safety data
- Current or recent history of significant bacterial, fungal, viral, or mycobacterial infection
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- History of myocardial infarction, congestive heart failure, or stroke
- History of psychotic disorder
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 |
|---|---|---|
| RhPDGF-BBAlso: ABSOLVEOne 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution. | Drug | ABSOLVE |
| PlaceboCollagen Wound Dressing wetted with buffer. | Other | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Week 0 - 24
Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.
Successful wound healing for at least two consecutive measurements. (Efficacy)
Time frame: Week 12
Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.
3 secondary outcomes
Wound Size
Time frame: Week 0 - 24
Wound Closure
Time frame: Week 0 - 24
Complication rate
Time frame: Week 0 - 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Luis Gonzalez, MD principal investigator
Centro Medico Militar, Guatemala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RhPDGF-BB in people with Diabetic Foot Ulcers, run by Lynch Biologics LLC at 1 site in Guatemala.
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 12 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sam Lynch, DMSc, DMD (615-218-1624, sam.lynch@lynchbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Week 0 - 24). The study lists 2 primary outcomes in all. 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 31 Jan 2017.