Diabetic Foot UlcersNCT00971048

Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

A study testing HP828-101 and Hydrogel/Hydrocolloid in people with Diabetic Foot Ulcers and Pressure Ulcers, run by Healthpoint at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To compare HP828-101 to standard of care for the management of partial or full thickness wounds Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcers, Pressure Ulcers
What is being tested?: HP828-101 and Hydrogel/Hydrocolloid
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 11 sitesUnited States
Study dates: Sep 2009to Jan 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart. For subjects that agree to have their wound photographed for the trial, a photo release consent form must be signed and documented as well.
Age 18 years or older, of either sex, and of any race or skin type, provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
Females, if of child-bearing potential, have a negative urine pregnancy test and agree to use acceptable contraception during the study. Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner.
Have a partial or full thickness PU on the foot or ankle or DFU of <= 6 months duration and between ≥1.0 and ≤ 12.0 cm² in area.
Are willing to make all required study visits.
Are willing to follow instructions, in the opinion of the Investigator.

Show all 9Show fewer

Have, within 12 weeks prior to randomization, a serum albumin level ≥ 2.0 g/dL (20 g/L); Alkaline phosphatase, AST, ALT, serum creatinine, and BUN levels < 3 x upper limit of normal; HbA1C ≤ 12%; and Hemoglobin >= 8 g/dL. The most recently obtained value must be evaluated against these criteria. Please refer to Appendix 18.1.5
Have arterial supply adequacy confirmed by an Ankle Brachial Index (ABI) >= 0.7 and ≤ 1.1 or if the ABI is > 1.1, either a TcPO2 >= 40 mmHg, as measured on the foot, or great toe pressure ≥ 50 mm/Hg,
For ulcers that will require surgical debridement prior to enrollment, the wound must be expected to remain a partial thickness wound after debridement.

Who cannot join

Have a known hypersensitivity to any of the test articles or their components.
Have received therapy with another investigational agent within thirty (30) days of Visit 1.
Are pregnant or nursing.
Have clinical evidence of bacterial or fungal infection of the wound per visual/clinical assessment.
Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy.
Have had documented osteomyelitis on the target ulcer leg within 6 months preceding the screening visit.

Show all 13Show fewer

Have severe edema of the target ulcer leg.
If being treated with Xenaderm, must stop treatment prior to enrolling in the study.
Have received treatment with glucocorticoids for > 10 consecutive days within 6 months prior to the start of the study.
Have received chemotherapy or radiation therapy within the past 5 years.
Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit (e.g., Apligraf®).
Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
Current therapy with systemic or topical antibiotics or systemic therapy with cytotoxic drugs.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Foot and Ankle Associates of Florida
Altamonte Springs, Florida, 32701
Trovare Clinical Research
Bakersfield, California, 93311
Absolute Foot Care
Chula Vista, California, 91910
Prigoff-Bowers LLP
Dallas, Texas, 75224
Richard Galperin, DPM
Dallas, Texas, 75224
Weil Foot and Ankle Institute
Des Plaines, Illinois, 60016
Roy Kroeker
Fresno, California, 93710
Innovative Medical Technologies
Los Angeles, California, 90063
Robert Wunderlich, DPM
San Antonio, Texas, 78212
San Diego Research Center
San Diego, California, 92103
Dixie Regional Wound Clinic
St. George, Utah, 84770

Other trials in United States

About this study

To compare HP828-101 to standard of care for the management of partial or full thickness wounds

Read the detailed description

The primary objective is to compare HP828-101 to standard of care for the management of partial or full thickness wounds, evaluated using the Bates Jensen Wound Assessment Tool (BWAT).

The secondary objectives are comparison of the proportion of subjects with wound closure by day 22, comparison of pain assessed using a visual analog scale (VAS), and evaluation of moist wound environment as per the BWAT.

Conditions: Diabetic Foot Ulcers, Pressure Ulcers
Being tested: HP828-101, Hydrogel/Hydrocolloid
Keywords: pressure ulcers, PU, diabetic foot ulcers, DFU, Bates-Jensen Wound Assessment
Medical subject headings: Diabetic Foot, Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HP828-101Device
Also called New device, no brand name identified-Code name is HP828-101
Topical test article applied once daily
Hydrogel/HydrocolloidDevice
Also called 3M Tegaderm Hydrogel for DFU, ConvaTec DuoDERM Hydroactive Gel for PU
Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily

Study groups in NCT00971048
Study group	Role	What they receive
HP828-101	Experimental	Not described Receives: Device: HP828-101
Standard of Care	Active comparator	For DFU SoC is a hydrogel. For PU SoC is a hydrocolloid gel. Receives: Device: Hydrogel/Hydrocolloid

What is being measured

The primary outcome is the main question the study is designed to answer.

Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Measured: 22 - 29 days

Secondary outcomes (3)

Number of Participants With Wound Closure by Day 22.
Measured: 22 days
Pain Assessed by a 100-mm VAS Scale.
100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)
Measured: At every visit: Day 8, Day 15, Day 22, Day 29
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Measured: At every visit: Day 8, Day 15, Day 22, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jan 2011

First posted3 Sep 2009 (estimated)
Study startSep 2009
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00971048
Sponsor's protocol ID: 828-101-09-013
Status last verified: Dec 2013
First submitted: 27 Aug 2009
Last updated: 27 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ovington LG. The evolution of wound management: ancient origins and advances of the past 20 years. Home Healthc Nurse. 2002 Oct;20(10):652-6. doi: 10.1097/00004045-200210000-00009.
PubMed 12394337
Winter GD. Formation of the scab and the rate of epithelisation of superficial wounds in the skin of the young domestic pig. 1962. J Wound Care. 1995 Sep;4(8):366-7; discussion 368-71. No abstract available.
PubMed 7553187
HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
PubMed 14087904
Andersen CA, Roukis TS. The diabetic foot. Surg Clin North Am. 2007 Oct;87(5):1149-77, x. doi: 10.1016/j.suc.2007.08.001.
PubMed 17936480
Frykberg RG. Epidemiology of the diabetic foot: ulcerations and amputations. Adv Wound Care. 1999 Apr;12(3):139-41. No abstract available.
PubMed 10655794
Sussman C, Bates-Jensen B. Wound Care - A Collaborative Practice Manual for Health Professionals. 3rd Ed. Philadelphia: Lippincott Williams & Wilkins, 2006.
Hess CT. Wound Care. 5th Ed ed. Philadelphia: Lippincott Williams & Wilkins, 2005.
Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T, Sheehan P, Veves A, Wiersma-Bryant L. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):680-92. doi: 10.1111/j.1524-475X.2006.00176.x. No abstract available.
PubMed 17199833
Agren MS. An amorphous hydrogel enhances epithelialisation of wounds. Acta Derm Venereol. 1998 Mar;78(2):119-22. doi: 10.1080/000155598433449.
PubMed 9534889
Whitney J, Phillips L, Aslam R, Barbul A, Gottrup F, Gould L, Robson MC, Rodeheaver G, Thomas D, Stotts N. Guidelines for the treatment of pressure ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):663-79. doi: 10.1111/j.1524-475X.2006.00175.x. No abstract available.
PubMed 17199832

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Diabetic Foot Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
ClinicalTrials.gov ID: NCT00971048
Acronym / sponsor ID: 828-101-09-013
Conditions: Diabetic Foot Ulcers, Pressure Ulcers
Keywords: pressure ulcers, PU, diabetic foot ulcers, DFU, Bates-Jensen Wound Assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: HealthpointIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 3 Sep 2009 (estimated)
Results: Posted 27 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare HP828-101 to standard of care for the management of partial or full thickness wounds

Detailed description

The primary objective is to compare HP828-101 to standard of care for the management of partial or full thickness wounds, evaluated using the Bates Jensen Wound Assessment Tool (BWAT).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HP828-101	Experimental	Device: HP828-101
Standard of Care	Active comparator	Device: Hydrogel/HydrocolloidFor DFU SoC is a hydrogel. For PU SoC is a hydrocolloid gel.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart. For subjects that agree to have their wound photographed for the trial, a photo release consent form must be signed and documented as well.
Age 18 years or older, of either sex, and of any race or skin type, provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
Females, if of child-bearing potential, have a negative urine pregnancy test and agree to use acceptable contraception during the study. Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner.
Have a partial or full thickness PU on the foot or ankle or DFU of <= 6 months duration and between ≥1.0 and ≤ 12.0 cm² in area.
Are willing to make all required study visits.

Key exclusion criteria (13 listed)

Have a known hypersensitivity to any of the test articles or their components.
Have received therapy with another investigational agent within thirty (30) days of Visit 1.
Are pregnant or nursing.
Have clinical evidence of bacterial or fungal infection of the wound per visual/clinical assessment.
Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy.

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
HP828-101Also: New device, no brand name identified-Code name is HP828-101Topical test article applied once daily	Device	HP828-101
Hydrogel/HydrocolloidAlso: 3M Tegaderm Hydrogel for DFU, ConvaTec DuoDERM Hydroactive Gel for PUHydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily	Device	Standard of Care

Primary outcome

Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.
Time frame: 22 - 29 days
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.

3 secondary outcomes

Number of Participants With Wound Closure by Day 22.
Time frame: 22 days
Pain Assessed by a 100-mm VAS Scale.
Time frame: At every visit: Day 8, Day 15, Day 22, Day 29
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Time frame: At every visit: Day 8, Day 15, Day 22, Day 29

Results and safety

Results posted to the registry on 27 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HP828-101 Treating DFU	30	29
Standard of Care Treating DFU	33	31
HP828-101 Treating PU	12	11
Standard of Care Treating PU	13	11

Primary outcome: Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.

Time frame: 22 - 29 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	HP828-101 Treating DFU n = 30	Standard of Care Treating DFU n = 33	HP828-101 Treating PU n = 12	Standard of Care Treating PU n = 13
Day 22	20.28 (0.89)	21.38 (0.85)	20.94 (1.63)	20.59 (1.57)
Day 29	20.12 (0.98)	18.71 (0.93)	19.78 (1.67)	17.28 (1.61)

Population analysed: Intent-to-Treat

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HP828-101 Treating DFU	2 of 30 (6.7%)	0 of 30 (0%)	Not reported
Standard of Care Treating DFU	0 of 33 (0%)	0 of 33 (0%)	Not reported
HP828-101 Treating PU	0 of 12 (0%)	0 of 12 (0%)	Not reported
Standard of Care Treating PU	1 of 13 (7.7%)	0 of 13 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12394337Ovington LG. The evolution of wound management: ancient origins and advances of the past 20 years. Home Healthc Nurse. 2002 Oct;20(10):652-6. doi: 10.1097/00004045-200210000-00009.
Background: PubMed 7553187Winter GD. Formation of the scab and the rate of epithelisation of superficial wounds in the skin of the young domestic pig. 1962. J Wound Care. 1995 Sep;4(8):366-7; discussion 368-71. No abstract available.
Background: PubMed 14087904HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
Background: PubMed 17936480Andersen CA, Roukis TS. The diabetic foot. Surg Clin North Am. 2007 Oct;87(5):1149-77, x. doi: 10.1016/j.suc.2007.08.001.
Background: PubMed 10655794Frykberg RG. Epidemiology of the diabetic foot: ulcerations and amputations. Adv Wound Care. 1999 Apr;12(3):139-41. No abstract available.
BackgroundSussman C, Bates-Jensen B. Wound Care - A Collaborative Practice Manual for Health Professionals. 3rd Ed. Philadelphia: Lippincott Williams & Wilkins, 2006.
BackgroundHess CT. Wound Care. 5th Ed ed. Philadelphia: Lippincott Williams & Wilkins, 2005.
Background: PubMed 17199833Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T, Sheehan P, Veves A, Wiersma-Bryant L. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):680-92. doi: 10.1111/j.1524-475X.2006.00176.x. No abstract available.
Background: PubMed 9534889Agren MS. An amorphous hydrogel enhances epithelialisation of wounds. Acta Derm Venereol. 1998 Mar;78(2):119-22. doi: 10.1080/000155598433449.
Background: PubMed 17199832Whitney J, Phillips L, Aslam R, Barbul A, Gottrup F, Gould L, Robson MC, Rodeheaver G, Thomas D, Stotts N. Guidelines for the treatment of pressure ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):663-79. doi: 10.1111/j.1524-475X.2006.00175.x. No abstract available.

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.

Innes Cargill, PhD study director

Healthpoint, Ltd

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HP828-101 and Hydrogel/Hydrocolloid in people with Diabetic Foot Ulcers and Pressure Ulcers, run by Healthpoint at 11 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 13 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 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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. 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?

Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. (time frame: 22 - 29 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00971048, which also lists 10 linked publications.

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 27 Jan 2014.