Trial Outcomes & Findings for DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes (NCT NCT01472432)

NCT ID: NCT01472432

Last Updated: 2016-10-11

Results Overview

Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome. Optic microscopy is used to evaluate the epithelialization of the wound.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 106 participants
• Primary outcome timeframe: 3 months of treatment with vildagliptin
• Results posted on: 2016-10-11

Participant Flow

Completed

Participant milestones

Measure	Placebo In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. placebo: Placebo is added to the standard good medical practice.	Vildagliptin The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.
Overall Study STARTED	53	53
Overall Study Ulcer Reduction	13	33
Overall Study COMPLETED	53	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=53 Participants In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. placebo: Placebo is added to the standard good medical practice.	Vildagliptin n=53 Participants The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 14 • n=5 Participants	64 years STANDARD_DEVIATION 15 • n=7 Participants	64 years STANDARD_DEVIATION 21 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Region of Enrollment Italy	53 participants n=5 Participants	53 participants n=7 Participants	106 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months of treatment with vildagliptin

Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.

Optic microscopy is used to evaluate the epithelialization of the wound.

Outcome measures

Measure	Placebo n=53 Participants In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. placebo: Placebo is added to the standard good medical practice.	Vildagliptin n=53 Participants The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.
Full Epithelialization of the Wound	16 participants	8 participants

PRIMARY outcome

Timeframe: 3 months of treatment with vildagliptin

Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.

Capillary density is measured using immunohistochemistry

Outcome measures

Measure	Placebo n=53 Participants In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. placebo: Placebo is added to the standard good medical practice.	Vildagliptin n=53 Participants The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.
Capillary Density baseline data	48 capillaries/mm2 Interval 15.0 to 80.0	46 capillaries/mm2 Interval 12.0 to 88.0
Capillary Density 3 months data	50 capillaries/mm2 Interval 20.0 to 90.0	140 capillaries/mm2 Interval 100.0 to 180.0

SECONDARY outcome

Timeframe: 3 months

The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.

Outcome measures

Measure	Placebo n=53 Participants In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. placebo: Placebo is added to the standard good medical practice.	Vildagliptin n=53 Participants The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.
HIF-1α 3 months data	200 arbitrary units Interval 150.0 to 400.0	600 arbitrary units Interval 380.0 to 800.0
HIF-1α Baseline data	205 arbitrary units Interval 96.0 to 350.0	215 arbitrary units Interval 60.0 to 400.0

SECONDARY outcome

Timeframe: 3 months

The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.

Outcome measures

Measure	Placebo n=53 Participants In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. placebo: Placebo is added to the standard good medical practice.	Vildagliptin n=53 Participants The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.
VEGF 3 months data	200 arbitrary units Interval 100.0 to 500.0	580 arbitrary units Interval 200.0 to 900.0
VEGF Baseline data	210 arbitrary units Interval 140.0 to 260.0	215 arbitrary units Interval 160.0 to 280.0

SECONDARY outcome

Timeframe: 3 months

Population: The analysis was not performed because an inadequate amount of biopsy tissue

The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The analysis was not performed because an inadequate amount of biopsy tissue

The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vildagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Raffaele Marfella

Second University Naples

Phone: ++390815665110

Email: raffaele.marfella@unina2.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place