Cochrane · systematic review · CD012235

Interventions for ulceration and other skin changes caused by nerve damage in leprosy

Reinar, LM, Forsetlund, L, Lehman, LF, et al. · Cochrane Database of Systematic Reviews · 2019 · Cochrane Library

SkinAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
100
current version
GRADE rated
40
No studies
59
Included studies
NR
No studies 59 · 59%Ungraded 1 · 1%Very low 39 · 39%Low 0 · 0%Moderate 1 · 1%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Zinc tape compared to magnesium sulphate glycerin for ulceration caused by nerve damage in leprosy

Population: ulceration caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcers
Zinc tape vs magnesium sulphate glycerin
no estimate extractedNRNo studies
Primary outcome: healing of ulcers (number of ulcers healed after 1 month)
Zinc tape vs magnesium sulphate glycerin
RR 2 [0.43, 9.21]1 study · 28 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcers (mean ulcer area (mm3)
Zinc tape vs magnesium sulphate glycerin
no estimate extracted1 study · 28 participantsVery low
Downgraded: risk of bias, imprecision
Priimary outcome: adverse events
Zinc tape vs magnesium sulphate glycerin
no estimate extractedNRNo studies
Secondary outcome: quality of life
Zinc tape vs magnesium sulphate glycerin
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Zinc tape vs magnesium sulphate glycerin
no estimate extractedNRNo studies
Secondary outcome: costs
Zinc tape vs magnesium sulphate glycerin
no estimate extractedNRNo studies

Zinc tape compared to povidone iodine (10%) for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
6 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcers
Zinc tape vs povidone iodine (10%)
no estimate extractedNRNo studies
Primary outcome: healing of ulcers (mean reduction of ulcer area at 6 weeks (mm2))
Zinc tape vs povidone iodine (10%)
no estimate extracted1 study · 38 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events
Zinc tape vs povidone iodine (10%)
no estimate extractedNRNo studies
Secondary outcome: quality of life
Zinc tape vs povidone iodine (10%)
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Zinc tape vs povidone iodine (10%)
no estimate extractedNRNo studies
Secondary outcome: costs
Zinc tape vs povidone iodine (10%)
no estimate extractedNRNo studies

Adhesive zinc tape compared to gauze soaked in eusol for ulceration caused by nerve damage in leprosy

Population: ulceration caused by nerve damage in leprosy
6 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcers
Adhesive zinc tape vs gauze soaked
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (days)
Adhesive zinc tape vs gauze soaked
no estimate extracted1 study · 90 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events (skin sensitisation at 2 months)
Adhesive zinc tape vs gauze soaked
no estimate extracted1 study · 90 participantsVery low
Downgraded: risk of bias, imprecision
Secondary outcome: quality of life
Adhesive zinc tape vs gauze soaked
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Adhesive zinc tape vs gauze soaked
no estimate extracted1 study · 90 participantsVery low
Downgraded: risk of bias, imprecision
Secondary outcome: costs
Adhesive zinc tape vs gauze soaked
no estimate extractedNRNo studies

Topical ketanserin (2%) compared to clioquinol cream (3%) or zinc paste for ulceration caused by nerve damage in leprosy

Population: ulceration caused by nerve damage in leprosy
6 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcers
Topical ketanserin (2%) vs clioquinol cream (3%) or zinc paste
no estimate extractedNRNo studies
Primary outcome: healing of ulcers (healing of ulcer at 3 months)
Topical ketanserin (2%) vs clioquinol cream (3%) or zinc paste
RR 6 [1.45, 24.75]1 study · 66 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events (assessed at 3 months as minimum, moderate or severe)
Topical ketanserin (2%) vs clioquinol cream (3%) or zinc paste
no estimate extracted1 study · 66 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Secondary outcome: quality of life
Topical ketanserin (2%) vs clioquinol cream (3%) or zinc paste
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Topical ketanserin (2%) vs clioquinol cream (3%) or zinc paste
no estimate extractedNRNo studies
Secondary outcome: cost of intervention
Topical ketanserin (2%) vs clioquinol cream (3%) or zinc paste
no estimate extractedNRNo studies

Topical phenytoin compared to saline dressing for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcers
Topical phenytoin vs saline dressing
no estimate extractedNRNo studies
Primary outcome: healing of ulcers (mean percentage of ulcer volume reduction at 4 weeks (Bansal 1993))
Topical phenytoin vs saline dressing
no estimate extracted1 study · 100 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcers (mean percentage reduction of ulcer size area at 4 weeks (Bhatia 2004))
Topical phenytoin vs saline dressing
no estimate extracted1 study · 23 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events (up to 4 weeks)
Topical phenytoin vs saline dressing
no estimate extracted2 studies · 123 participantsVery low
Downgraded: risk of bias, imprecision
Secondary outcome: quality of life
Topical phenytoin vs saline dressing
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Topical phenytoin vs saline dressing
no estimate extractedNRNo studies
Secondary outcome: cost of intervention
Topical phenytoin vs saline dressing
no estimate extractedNRNo studies

Footwear ‐ canvas shoes compared to PVC boots for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer (number of persons developing new ulcers at 1 year)
Footwear ‐ canvas shoes vs PVC boots
no estimate extracted1 study · 72 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcer (number of persons being ulcer‐free at 1 year)
Footwear ‐ canvas shoes vs PVC boots
RR 1.16 [0.77, 1.74]1 study · 38 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcer (number of persons having ulcers not healed at 1 year)
Footwear ‐ canvas shoes vs PVC boots
RR 0.52 [0.15, 1.75]1 study · 38 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events
Footwear ‐ canvas shoes vs PVC boots
no estimate extracted1 study · 38 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Secondary outcome: quality of life
Footwear ‐ canvas shoes vs PVC boots
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Footwear ‐ canvas shoes vs PVC boots
no estimate extracted1 study · 110 participantsModerate
Downgraded: risk of bias
Secondary outcome: costs
Footwear ‐ canvas shoes vs PVC boots
no estimate extracted1 study · 110 participantsUngraded

Padded moulded double‐rocker plaster shoe compared to padded below‐knee plaster for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
6 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
Padded moulded double‐rocker plaster shoe vs padded below‐knee plaster
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (ulcers fully or nearly healed at 6 weeks)
Padded moulded double‐rocker plaster shoe vs padded below‐knee plaster
RR 0.96 [0.77, 1.19]1 study · 55 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Primary outcome: adverse events
Padded moulded double‐rocker plaster shoe vs padded below‐knee plaster
no estimate extractedNRNo studies
Secondary outcome: quality of life
Padded moulded double‐rocker plaster shoe vs padded below‐knee plaster
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Padded moulded double‐rocker plaster shoe vs padded below‐knee plaster
no estimate extracted1 study · 55 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Secondary outcome: costs of intervention
Padded moulded double‐rocker plaster shoe vs padded below‐knee plaster
no estimate extracted1 study · 55 participantsVery low
Downgraded: risk of bias, imprecision, indirectness

Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) compared to self‐care and footwear for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (at 4 to 5 weeks)
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extracted1 study · 33 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome 2 (healing of ulcer): Mean volume of ulcers at four to five weeks
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extracted1 study · 33 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome 3 (adverse events)
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extractedNRNo studies
Secondary outcome 1 (quality of life)
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extractedNRNo studies
Secondary outcome 2 (acceptability of treatment)
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extractedNRNo studies
Secondary outcome 3 (cost of intervention)
Exposure to pulsed magnetic fields (in addition to self‐care and protective footwear) vs self‐care and footwear
no estimate extracted1 study · 33 participantsVery low
Downgraded: risk of bias, imprecision

Low‐level laser therapy compared to simple dressing for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
Low‐level laser therapy vs simple dressing
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (size of ulcer (area) at 12 weeks (cm2))
Low‐level laser therapy vs simple dressing
no estimate extracted1 study · 23 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Primary outcome: healing of ulcer (size of ulcer (depth) at 12 weeks (mm))
Low‐level laser therapy vs simple dressing
no estimate extracted1 study · 23 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Primary outcome: adverse effects
Low‐level laser therapy vs simple dressing
no estimate extractedNRNo studies
Secondary outcome: quality of life
Low‐level laser therapy vs simple dressing
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Low‐level laser therapy vs simple dressing
no estimate extractedNRNo studies
Secondary outcome: costs
Low‐level laser therapy vs simple dressing
no estimate extracted1 study · 23 participantsVery low
Downgraded: risk of bias, imprecision, indirectness

Intralesional pentoxifylline compared to daily simple dressing for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
Intralesional pentoxifylline vs daily simple dressing
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (complete healing of ulcer at 4 weeks)
Intralesional pentoxifylline vs daily simple dressing
OR 9 [1.64, 49.45]1 study · 40 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcer (ulcer depth (cm) at 4 weeks)
Intralesional pentoxifylline vs daily simple dressing
no estimate extracted1 study · 40 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events (at 4 weeks)
Intralesional pentoxifylline vs daily simple dressing
no estimate extracted1 study · 40 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Secondary outcome: quality of life
Intralesional pentoxifylline vs daily simple dressing
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Intralesional pentoxifylline vs daily simple dressing
no estimate extractedNRNo studies
Secondary outcome: cost of intervention
Intralesional pentoxifylline vs daily simple dressing
no estimate extractedNRNo studies

Light‐emitting diode (LED) irradiation compared to conventional dressing therapy for ulceration and other skin changes caused by nerve damage in leprosy

Population: ulceration and other skin changes caused by nerve damage in leprosy
6 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
Light‐emitting diode (LED) irradiation vs conventional dressing therapy
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (mean change of wound size (mm3) after 8 months treatment)
Light‐emitting diode (LED) irradiation vs conventional dressing therapy
no estimate extracted1 study · 60 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events
Light‐emitting diode (LED) irradiation vs conventional dressing therapy
no estimate extractedNRNo studies
Secondary outcome: quality of life
Light‐emitting diode (LED) irradiation vs conventional dressing therapy
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
Light‐emitting diode (LED) irradiation vs conventional dressing therapy
no estimate extractedNRNo studies
Secondary outcome: cost of intervention
Light‐emitting diode (LED) irradiation vs conventional dressing therapy
no estimate extractedNRNo studies

Wax therapy compared to foot soaks for skin changes caused by nerve damage in leprosy

Population: skin changes caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: healing of ulcer
Wax therapy vs foot soaks
no estimate extractedNRNo studies
Tertiary outcome: prevention and treatment of other skin changes (number of feet being fissure‐ and callous‐free at 6 weeks)
Wax therapy vs foot soaks
RR 2.22 [1.07, 4.6]1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Primary outcome: prevention of ulcer
Wax therapy vs foot soaks
no estimate extractedNRNo studies
Primary outcome: adverse effects
Wax therapy vs foot soaks
no estimate extractedNRNo studies
Secondary outcome: quality of life
Wax therapy vs foot soaks
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment (at 6 weeks)
Wax therapy vs foot soaks
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Secondary outome: cost of intervention
Wax therapy vs foot soaks
no estimate extractedNRNo studies

hAMMSC‐CM + vitamin C compared to hAMMSC‐CM for ulceration caused by nerve damage in leprosy

Population: ulceration caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (size, cm², at 8 weeks)
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcer (depth, cm², at 8 weeks)
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Secondary outcome: quality of life
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extractedNRNo studies
Secondary outome: cost of intervention
hAMMSC‐CM + vitamin C vs hAMMSC‐CM
no estimate extractedNRNo studies

hAMMSC‐CM + vitamin E compared to hAMMSC‐CM for ulceration caused by nerve damage in leprosy

Population: ulceration caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (size, cm2 at 8 weeks)
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcer (depth, cm2 at 8 weeks)
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Secondary outcome: quality of life
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extractedNRNo studies
Secondary outome: cost of intervention
hAMMSC‐CM + vitamin E vs hAMMSC‐CM
no estimate extractedNRNo studies

hAMMSC‐CM + vitamin E compared to hAMMSC‐CM + vitamin C for ulceration caused by nerve damage in leprosy

Population: ulceration caused by nerve damage in leprosy
7 questions
OutcomeEffectEvidenceStatus / GRADE
Primary outcome: prevention of ulcer
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extractedNRNo studies
Primary outcome: healing of ulcer (size, cm2, at 8 weeks)
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: healing of ulcer (depth, cm2, at 8 weeks)
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Primary outcome: adverse events
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extracted1 study · 44 participantsVery low
Downgraded: risk of bias, imprecision
Secondary outcome: quality of life
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extractedNRNo studies
Secondary outcome: acceptability of treatment
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extractedNRNo studies
Secondary outome: cost of intervention
hAMMSC‐CM + vitamin E vs hAMMSC‐CM + vitamin C
no estimate extractedNRNo studies