Assessment of Wound Closure Comparing Synthetic Hybrid-Sc... | NCT04927702

NCT04927702

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Experimental	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)	Device: Synthetic Hybrid-Scale Fiber Matrix
Diabetic Foot Ulcer Participants Assigned to Standard of Care	Active Comparator	Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)	Device: Standard of Care
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Experimental	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)	Device: Synthetic Hybrid-Scale Fiber Matrix
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Active Comparator	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)	Device: Living Cellular Skin Substitute

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synthetic Hybrid-Scale Fiber Matrix	Device	A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound	The number of wounds in each treatment arm that achieved 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization	12 weeks
For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound	The number of wounds in each treatment arm with 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage Change in Wound Area	Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements. Mean percent wound change will be calculated for each treatment arm/group with Week 1 as the baseline value. Change is calculated using the 2-week follow up visit after wound closure for wounds that achieved closure, or for wounds that did not achieve closure, the Week 12 wound area for DFUs and Week 16 wound area for VLUs.

Eligibility Module

Eligibility Criteria

Inclusion Criteria for Participants with Diabetic Foot Ulcers:

Participant is at least 18 years old
Participant is willing and capable of complying with all protocol requirements
Participant or legally authorized representative (LAR) is willing to provide written informed consent
Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
Ulcer(s) must be located at least in part on the foot or ankle
Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
Wound size must be >1.0 cm^2 and < 25 cm^2 on the day of randomization and initial application of the study product, after initial debridement
Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
1. Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥40mmHg, OR
2. Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR
3. Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5

Exclusion Criteria for Participants with Diabetic Foot Ulcers:

Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
Participant is pregnant, breast feeding or planning to become pregnant
Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
Participant has a life expectancy less than six months as assessed by the investigator
Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period
Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
Hgb A1c > 12 percent within 3 months prior to randomization
Participant not in reasonable metabolic control in the judgment of the investigator
Participant with a known history of poor compliance with medical treatments
Participant currently undergoing cancer treatment
Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s)
Study ulcer(s) experiences greater than 30 percent reduction over the 2-week screening period
Participant also has a venous leg ulcer that is enrolled into this study

Inclusion Criteria for Participants with Venous Leg Ulcers:

Participant is at least 18 years old
Participant is willing and capable of complying with all protocol requirements
Participant or legally authorized representative (LAR) is willing to provide written informed consent
Participant has peripheral venous disease per investigator judgment or diagnostic confirmation
Ulcer(s) must be venous in origin, located on a lower extremity
Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
Wound(s) size must be >1.0 cm^2 and < 50 cm^2 on the day of randomization and initial application of the study product, after initial debridement
Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
1. Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥ 40mmHg, OR
2. Ankle-brachial index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.52, OR
3. Toe-Brachial Index (TBI) of study leg(s) with results of ≥ 0.5, OR
4. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg(s)

Exclusion Criteria for Participants with Venous Leg Ulcers:

Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
Participant is pregnant, breast feeding or planning to become pregnant
Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
Participant has a known allergy to bovine materials or agarose shipping materials
Participant has a life expectancy less than six months as assessed by the investigator
Participant has received skin substitutes during the screening period or within 14 days prior to the beginning of the screening period
Participant has an additional wound within 3 cm of the study wound or study wounds are less than 3 cm apart
Hgb A1c > 12 percent within 3 months prior to randomization in patients with a known history of diabetes
Participant is not in reasonable metabolic control in the judgment of the investigator
Participant has a known history of poor compliance with medical treatments
Participant currently undergoing cancer treatment
Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
Participant unwilling or unable to tolerate use of compression therapy for the duration of the study
Study ulcer(s) experiences greater than 30 percent reduction over the 2-week run-in period
Participant also has a diabetic foot ulcer that is enrolled into this study

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
ILD Research Center		Vista	California	92083	United States
University of Florida - Jacksonville

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 30, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

FG0008 subjects9 units

FG00110 subjects10 units

FG00214 subjects15 units

FG00316 subjects19 units

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
BG001	Diabetic Foot Ulcer Participants Assigned to Standard of Care	Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
BG002	Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
BG003	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG00110 BG00214 BG00316 BG00448

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00067± 12.6 BG00153± 14.5 BG00259± 10.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Wound area at baseline in cm^2

Mean

Standard Deviation

cm^2

Title

Denominators

Categories

Title	Measurements
	BG0003.0± 1.2 BG0015.0± 4.4 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound

The number of wounds in each treatment arm that achieved 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization

Posted

Count of Units

wounds

12 weeks

wounds

ID	Title	Description
OG000	Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
OG001	Diabetic Foot Ulcer Participants Assigned to Standard of Care	Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.

Units	Counts
Participants	OG0002 OG0016
wounds	OG0002 OG001

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0011

Primary

For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound

The number of wounds in each treatment arm with 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization

Posted

Count of Units

wounds

16 weeks

wounds

ID	Title	Description
OG000	Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
OG001	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.

Secondary

Percentage Change in Wound Area

Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements. Mean percent wound change will be calculated for each treatment arm/group with Week 1 as the baseline value. Change is calculated using the 2-week follow up visit after wound closure for wounds that achieved closure, or for wounds that did not achieve closure, the Week 12 wound area for DFUs and Week 16 wound area for VLUs.

Positive numbers represent increases and negative numbers to represent decreases

Posted

Mean

Standard Deviation

Percentage change

Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.

wounds

ID	Title	Description
OG000	Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
OG001	Diabetic Foot Ulcer Participants Assigned to Standard of Care	Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.

Secondary

Time to 100 Percent Epithelialization

The number of weeks from initial application of study product until 100 percent epithelialization is first identified.

Posted

Mean

Standard Deviation

Weeks

12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first.

Wounds

ID	Title	Description
OG000	Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
OG001	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
OG002	Diabetic Foot Ulcer Participants Assigned to Standard of Care (SOC)

Secondary

Total Number of Product Applications

The number of study applications including the initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first

ITT population

Posted

Mean

Standard Deviation

Number of applications

Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first

Wounds

ID	Title	Description
OG000	Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
OG001	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
OG002

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.	8	0	8	3	8
EG001	Diabetic Foot Ulcer Participants Assigned to Standard of Care	Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.	10	3	10	4	10
EG002	Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.	14	1	14	8	14
EG003	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first) Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.	16	0	16	3	16

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG0030 events0 affected16 at risk
Amputation	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected14 at risk EG003
Atherectomy	Investigations	Non-systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected14 at risk EG003
Pain near wound	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected14 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Wound NOS	Injury, poisoning and procedural complications	Non-systematic Assessment	non-site specific injury	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected14 at risk EG0031 events1 affected16 at risk
Wound infection staphylococcal	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Infestation	Infections and infestations	Non-systematic Assessment	maggots in wound	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected14 at risk EG003
skin ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	new ulceration	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected14 at risk EG003
influenza like illness	General disorders	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Lower respiratory tract signs and symptoms	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Pseudomonal infections	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Osteomyelitis	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Radiofrequency ablation	Surgical and medical procedures	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Cardiac Murmur	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Covid-19	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Wound erythema	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Wound Infection	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected14 at risk EG003
Blister	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected14 at risk EG003
Arteriovenous fistula	Vascular disorders	Non-systematic Assessment		EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected14 at risk EG003
Facial skin infection	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected14 at risk EG003
Skin lesion excision	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected14 at risk EG003
Headache	General disorders	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected14 at risk EG003
Joint injury	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected14 at risk EG003
limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected14 at risk EG003

Early termination leading to small numbers of subjects analyzed

Certain Agreements

First MCP Posted Date

ID	Term
D017719	Diabetic Foot
D014647	Varicose Ulcer

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer
D007871	Leg Ulcer
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
D003929	Diabetic Neuropathies
D014648	Varicose Veins

Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)