Diabetic Foot UlcersPhase 1/2NCT01098357
Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
A Phase 1/2 study testing Biochaperone PDGF-BB Low dose, Biochaperone PDGF-BB High dose and Regranex in people with Diabetic Foot Ulcers, run by Virchow Group at 7 sites in India.
Trial summary
This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study. Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Biochaperone PDGF-BB Low dose, Biochaperone PDGF-BB High dose and Regranex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 7 sitesIndia
- Study dates
- Jun 2010to Sep 2011
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
- Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification).
- Chronic ulcer of at least six weeks despite appropriate wound care.
- Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
- Well controlled infection or cellulitis (systemic antibiotherapy).
- Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
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- Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
- Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
- Signed informed consent before any study procedure.
Who cannot join
- Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
- Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
- Active osteomyelitis affecting the area of the target ulcer.
- Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
- Known connective tissue or malignant disease.
- Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
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- Use of investigational drug/device within 30 days.
- Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
- Vascular reconstruction within 8 weeks. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Jain Institute of Vascular sciences
Bangalore, Karnataka, 560052
Karnataka Institute of Diabetology
Bangalore, Karnataka, 560069
M.V. Hospital for Diabetes
Chennai, Tamil Nadu, 600013
Lakeshore Hospital & Research Centre Ltd
Kochi, Kerala, 682 040
S.K. Diabetes Research & Education Centre
Kolkata, West Bengal, 700 009
Joshi Hospital , Maharashra Medical Foundation
Pune, Maharashtra
Vijay Vachharajani Memorial
Rajkot, Gujarat
About this study
Official title: A Phase I/II, Multicentre, Randomised, Controlled, and Open-label Trial Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
Read the detailed description
After the screening visit, the eligible patient population randomly receive one of the three following topical drugs:
- BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,
- BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or
- BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or
- Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Biochaperone PDGF-BB Low dose, Biochaperone PDGF-BB High dose, Regranex, Biochaperone PDGF-BB Very Low Dose
- Keywords
- rhPDGF, diabetic foot ulcer,
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochaperone PDGF-BB Low doseDrug
Also called BC low dose
BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks
Biochaperone PDGF-BB High doseDrug
Also called BC high dose
BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks
RegranexDrug
Also called Becaplermin
Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks
Biochaperone PDGF-BB Very Low DoseDrug
Also called BC Very low dose
BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
| Study group | Role | What they receive |
|---|---|---|
| Biochaperone PDGF-BB low dose | Experimental | BioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial. Receives: Drug: Biochaperone PDGF-BB Low dose |
| Biochaperone PDGF-BB High dose | Experimental | BioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial. Receives: Drug: Biochaperone PDGF-BB High dose |
| Regranex | Active comparator | Becaplermin gel (Regranex® Gel 0.01%, Systagenix, formerly and Johnson \& Johnson) is a topical gel of rhPDGF-BB conditioned in a gel tube. Receives: Drug: Regranex |
| Very Low Dose BioChaperone PDGF-BB | Experimental | BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application Receives: Drug: Biochaperone PDGF-BB Very Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete wound closure
Incidence of complete wound closure
Measured: 20 WEEKS
Secondary outcomes (4)
Time to achieve complete wound closure
Time to achieve complete wound closure
Measured: Study duration 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Measured: Study duration 20 weeks
Incidence of complete wound healing at week 10
Measured: 10 weeks
Safety Safety Measures
- Treatment emergent adverse events with investigator's assessment of seriousness, severity, duration and relationship to study medication
- Wound-related infections
- Changes in standard laboratory tests (hematology, biochemistry and detection of antibodies)
Measured: Study duration 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionSep 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virchow Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adocia
- Responsible party
- Sponsor
- Investigators
- T C Raghuram, MD, Phd, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098357
- Sponsor's protocol ID
- BC1-CT1
- Status last verified
- Aug 2012
- First submitted
- 1 Apr 2010
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multicentre, Randomised, Controlled, and Open-label Trial Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT01098357
- Acronym / sponsor ID
- BC1-CT1
- Conditions
- Diabetic Foot Ulcers
- Keywords
- rhPDGF, diabetic foot ulcer,
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Virchow GroupIndustry (pharma, biotech, devices)
- Collaborators
- Adocia
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Apr 2010 (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.
This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
Detailed description
After the screening visit, the eligible patient population randomly receive one of the three following topical drugs:
- BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,
- BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or
- BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or
- Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biochaperone PDGF-BB low dose | Experimental | Drug: Biochaperone PDGF-BB Low doseBioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial. |
| Biochaperone PDGF-BB High dose | Experimental | Drug: Biochaperone PDGF-BB High doseBioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial. |
| Regranex | Active comparator | Drug: RegranexBecaplermin gel (Regranex® Gel 0.01%, Systagenix, formerly and Johnson \& Johnson) is a topical gel of rhPDGF-BB conditioned in a gel tube. |
| Very Low Dose BioChaperone PDGF-BB | Experimental | Drug: Biochaperone PDGF-BB Very Low DoseBioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
- Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification).
- Chronic ulcer of at least six weeks despite appropriate wound care.
- Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
- Well controlled infection or cellulitis (systemic antibiotherapy).
Key exclusion criteria (9 listed)
- Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
- Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
- Active osteomyelitis affecting the area of the target ulcer.
- Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
- Known connective tissue or malignant disease.
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 |
|---|---|---|
| Biochaperone PDGF-BB Low doseAlso: BC low doseBioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks | Drug | Biochaperone PDGF-BB low dose |
| Biochaperone PDGF-BB High doseAlso: BC high doseBioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks | Drug | Biochaperone PDGF-BB High dose |
| RegranexAlso: BecaplerminRegranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks | Drug | Regranex |
| Biochaperone PDGF-BB Very Low DoseAlso: BC Very low doseBioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application | Drug | Very Low Dose BioChaperone PDGF-BB |
Primary outcome
Incidence of complete wound closure
Time frame: 20 WEEKS
Incidence of complete wound closure
4 secondary outcomes
Time to achieve complete wound closure
Time frame: Study duration 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Time frame: Study duration 20 weeks
Incidence of complete wound healing at week 10
Time frame: 10 weeks
Safety Safety Measures
Time frame: Study duration 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
T C Raghuram, MD, Phd study director
Medical Director
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biochaperone PDGF-BB Low dose, Biochaperone PDGF-BB High dose and Regranex in people with Diabetic Foot Ulcers, run by Virchow Group at 7 sites in India.
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 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: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of complete wound closure (time frame: 20 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 15 Dec 2014.